6 Clinical Review jobs in the Philippines
Clinical Review Specialist - EDS (Day Shift & Fully Remote)
ThermoFisher Scientific
Posted 4 days ago
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our Clinical Data Management team supervises all data collected in a clinical trial. This work spans the design and build of the EDC database, ingestion of all digital and vendor data sources, comprehensive data review and validation with a focus on high quality delivery of clinical trial data. We work closely with our project teams and customers across all therapeutic areas incorporating innovative technology and best practices to help our customers deliver life-changing therapies.
+ **Office Location:** Seven/NEO Building, Bonifacio Global City, Taguig City, Philippines
+ **Shift Schedule:** Day Shift - flexible hours (8:00 AM to 5:00 PM)
+ **Work Arrangement:** Fully Remote
**Discover Impactful Work:**
The **Clinical Review Specialist** reviews patient data in accordance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs)/Working Practice Documents (WPDs) and Data Validation Manuals (DVMs). Clinical Review Specialists will be expected to collaborate closely with colleagues in other functional groups as required, and to connect with management for all data review activities within their allocated studies
**A day in the Life:**
Understands project protocols and the Data Validation Manuals (DVMs) and applies relevant components to daily tasks.
+ Reviews patient data and generates and manages manual queries in accordance with the Manual Data Review Plan (MDRP) in the DVM and Client expectations.
+ Identifies data issues and works with the Early Development Services team and study sites to resolve
+ Ensures applicable data review activities are conducted accurately, and all related deliverables are completed to quality expectations, within budget and on time.
+ Provides support, guidance and direction on clinical data review to the Clinical Data Management (CDM) project team.
+ Performs assigned clinical review and data management activities independently and efficiently, with attention to quality.
**Keys to Success:**
**Education**
+ **Bachelor's Degree Graduate in any Life Science or Healthcare-related Courses** (i.e. Pharmacy, Nursing, Medical Technology, Biology, etc.)
**Experience**
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
**Knowledge, Skills, Abilities**
+ Ability to effectively apply knowledge and skills in a highly organized fashion utilizing adherence to regulatory guidelines, SOPs and client expectations
+ Excellent understanding of pharmaceutical/clinical/medical terminology
+ Skilled in interactive computer programs
+ Good written/ verbal communication skills with a strong command of English language and grammar
+ Excellent organizational, analytical/problem solving skills and attention to detail
+ Ability to work productively with minimal supervision
+ Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
+ Strong customer focus and excellent interpersonal skills
+ Proven flexibility and adaptability when working in a team and independently using excellent judgment in making decisions
+ Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands
**Physical Requirements / Work Environment**
+ · Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
+ Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
+ Frequently interacts with others to obtain or relate information to diverse groups.
+ Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
+ Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
+ Regular and consistent attendance
**What we offer**
At PPD, we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you.
**Benefits**
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our Clinical Data Management team supervises all data collected in a clinical trial. This work spans the design and build of the EDC database, ingestion of all digital and vendor data sources, comprehensive data review and validation with a focus on high quality delivery of clinical trial data. We work closely with our project teams and customers across all therapeutic areas incorporating innovative technology and best practices to help our customers deliver life-changing therapies.
+ **Office Location:** Seven/NEO Building, Bonifacio Global City, Taguig City, Philippines
+ **Shift Schedule:** Day Shift - flexible hours (8:00 AM to 5:00 PM)
+ **Work Arrangement:** Fully Remote
**Discover Impactful Work:**
The **Clinical Review Specialist** reviews patient data in accordance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs)/Working Practice Documents (WPDs) and Data Validation Manuals (DVMs). Clinical Review Specialists will be expected to collaborate closely with colleagues in other functional groups as required, and to connect with management for all data review activities within their allocated studies
**A day in the Life:**
Understands project protocols and the Data Validation Manuals (DVMs) and applies relevant components to daily tasks.
+ Reviews patient data and generates and manages manual queries in accordance with the Manual Data Review Plan (MDRP) in the DVM and Client expectations.
+ Identifies data issues and works with the Early Development Services team and study sites to resolve
+ Ensures applicable data review activities are conducted accurately, and all related deliverables are completed to quality expectations, within budget and on time.
+ Provides support, guidance and direction on clinical data review to the Clinical Data Management (CDM) project team.
+ Performs assigned clinical review and data management activities independently and efficiently, with attention to quality.
**Keys to Success:**
**Education**
+ **Bachelor's Degree Graduate in any Life Science or Healthcare-related Courses** (i.e. Pharmacy, Nursing, Medical Technology, Biology, etc.)
**Experience**
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
**Knowledge, Skills, Abilities**
+ Ability to effectively apply knowledge and skills in a highly organized fashion utilizing adherence to regulatory guidelines, SOPs and client expectations
+ Excellent understanding of pharmaceutical/clinical/medical terminology
+ Skilled in interactive computer programs
+ Good written/ verbal communication skills with a strong command of English language and grammar
+ Excellent organizational, analytical/problem solving skills and attention to detail
+ Ability to work productively with minimal supervision
+ Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
+ Strong customer focus and excellent interpersonal skills
+ Proven flexibility and adaptability when working in a team and independently using excellent judgment in making decisions
+ Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands
**Physical Requirements / Work Environment**
+ · Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
+ Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
+ Frequently interacts with others to obtain or relate information to diverse groups.
+ Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
+ Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
+ Regular and consistent attendance
**What we offer**
At PPD, we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you.
**Benefits**
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
0
PHRN - Utilization Review / Clinical Authorization
Taguig, National Capital Region
HRTX
Posted 7 days ago
Job Viewed
Job Description
We're Hiring: PHRN Quality Auditor Clinical Services
Location: Onsite, Mckinley, Taguig
Schedule: Night Shift | Monday to Friday
Hiring Target Date: Preferably by July 21, 2025
Salary Range: Up to 50k
Must hold an active PHRN license (Not a USRN holder)
Prior experience as a Quality Auditor in a healthcare BPO clinical setting
Alternatively, 4 to 7 years of specialized experience in Clinical Authorization or Utilization Review
Strong knowledge of EPIC , MCG , or InterQual guidelines
Must have a stable work history with minimal employment transitions
- Conduct audits in accordance with Quality Improvement Plans (QIP)
- Provide actionable feedback to team members and track corrections
- Escalate compliance concerns, trends, and anomalies to leadership
- Stay updated through production work and active participation in process updates
- Join client calls to ensure accurate capture of updates and compliance
- Verify patient insurance eligibility, benefits, and requirements with payers
- Request, track, and secure pre-authorizations for medical services and procedures
- Review and follow up on oncology chemotherapy drug authorizations
- Ensure HIPAA compliance and maintain proper documentation in EHR
- Handle medical necessity documentation and assist in denial appeals
- Prioritize cases based on urgency and patient impact
- Communicate with insurance companies, healthcare providers, and patients as needed
- Address clinical inquiries based on payer medical policy guidelines
This advertiser has chosen not to accept applicants from your region.
1
Clinical Data Associate
Taguig, National Capital Region
PPD
Posted today
Job Viewed
Job Description
**JOB DESCRIPTION**:
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Are you a data and a people person? Here’s your team. We manage and clean the data collected in a clinical trial — from the design and build of the database and edit checks, through the entry and cleaning of data to the final delivery of clinical trial data. We work closely with the project teams and clients to identify best practices and processes, meet and exceed our clients’ needs, and do the right thing to earn their trust.
As a Clinical Data Associate II, you will help ensure the highest quality of data and effectiveness of CDM Projects. You will work to provide data entry and validation of CDM projects within a fast-paced environment.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Summarized Purpose:
Performs advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs/WPDs, to assess the safety and efficacy of investigational products and/or medical devices.
Essential Functions:
- Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required.
- Generates, tracks and resolves data clarifications and queries. May implement CRF design in identified graphic design package.
- Reviews data listings for accuracy and consistency of data. Analyzes and resolves data validation and other data management reports.
- Produces project-specific status reports for CDM management and for clients on a regular basis.
- Performs data management activities such as Serious Adverse Event and Third-Party Vendor reconciliations as well as Data Listing reviews.
**Job Qualification**:
Education/Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills & Abilities:
- Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations
- Strong attention to detail and skill with numbers and ability to use interactive computer programs
- Good written and verbal communication skills and a strong command of English language and grammar
- Good organizational and analytical/problem-solving skills
- Ability to work productively with moderate supervision
- Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
- Strong customer focus and excellent interpersonal skills.
- Proven flexibility, adaptability and ability to work in a team environment or independently as needed
- Must demonstrate good judgment in making decisions
- Knowledge of medical/clinical trial terminology
- Understands project protocol and Data Validation Manual
Working Environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. 10-20% annual possible.
PPD Defining Principles:
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD
**Diversity Statement**:
- PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Are you a data and a people person? Here’s your team. We manage and clean the data collected in a clinical trial — from the design and build of the database and edit checks, through the entry and cleaning of data to the final delivery of clinical trial data. We work closely with the project teams and clients to identify best practices and processes, meet and exceed our clients’ needs, and do the right thing to earn their trust.
As a Clinical Data Associate II, you will help ensure the highest quality of data and effectiveness of CDM Projects. You will work to provide data entry and validation of CDM projects within a fast-paced environment.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Summarized Purpose:
Performs advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs/WPDs, to assess the safety and efficacy of investigational products and/or medical devices.
Essential Functions:
- Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required.
- Generates, tracks and resolves data clarifications and queries. May implement CRF design in identified graphic design package.
- Reviews data listings for accuracy and consistency of data. Analyzes and resolves data validation and other data management reports.
- Produces project-specific status reports for CDM management and for clients on a regular basis.
- Performs data management activities such as Serious Adverse Event and Third-Party Vendor reconciliations as well as Data Listing reviews.
**Job Qualification**:
Education/Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills & Abilities:
- Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations
- Strong attention to detail and skill with numbers and ability to use interactive computer programs
- Good written and verbal communication skills and a strong command of English language and grammar
- Good organizational and analytical/problem-solving skills
- Ability to work productively with moderate supervision
- Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
- Strong customer focus and excellent interpersonal skills.
- Proven flexibility, adaptability and ability to work in a team environment or independently as needed
- Must demonstrate good judgment in making decisions
- Knowledge of medical/clinical trial terminology
- Understands project protocol and Data Validation Manual
Working Environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. 10-20% annual possible.
PPD Defining Principles:
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD
**Diversity Statement**:
- PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
This advertiser has chosen not to accept applicants from your region.
2
Clinical Data Associate
Taguig, National Capital Region
PPD
Posted today
Job Viewed
Job Description
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Are you a data and a people person? Here’s your team. We manage and clean the data collected in a clinical trial — from the design and build of the database and edit checks, through the entry and cleaning of data to the final delivery of clinical trial data. We work closely with the project teams and clients to identify best practices and processes, meet and exceed our clients’ needs, and do the right thing to earn their trust.
As a Clinical Data Associate II, you will help ensure the highest quality of data and effectiveness of CDM Projects. You will work to provide data entry and validation of CDM projects within a fast-paced environment.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Summarized Purpose:
Performs advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs/WPDs, to assess the safety and efficacy of investigational products and/or medical devices.
Essential Functions:
- Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required.- Generates, tracks and resolves data clarifications and queries. May implement CRF design in identified graphic design package.- Reviews data listings for accuracy and consistency of data. Analyzes and resolves data validation and other data management reports.- Produces project-specific status reports for CDM management and for clients on a regular basis.- Performs data management activities such as Serious Adverse Event and Third-Party Vendor reconciliations as well as Data Listing reviews.
Education/Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills & Abilities:
- Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations- Strong attention to detail and skill with numbers and ability to use interactive computer programs- Good written and verbal communication skills and a strong command of English language and grammar- Good organizational and analytical/problem-solving skills- Ability to work productively with moderate supervision- Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data- Strong customer focus and excellent interpersonal skills.- Proven flexibility, adaptability and ability to work in a team environment or independently as needed- Must demonstrate good judgment in making decisions- Knowledge of medical/clinical trial terminology- Understands project protocol and Data Validation Manual
Working Environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. 10-20% annual possible.
PPD Defining Principles:
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD
Are you a data and a people person? Here’s your team. We manage and clean the data collected in a clinical trial — from the design and build of the database and edit checks, through the entry and cleaning of data to the final delivery of clinical trial data. We work closely with the project teams and clients to identify best practices and processes, meet and exceed our clients’ needs, and do the right thing to earn their trust.
As a Clinical Data Associate II, you will help ensure the highest quality of data and effectiveness of CDM Projects. You will work to provide data entry and validation of CDM projects within a fast-paced environment.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Summarized Purpose:
Performs advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs/WPDs, to assess the safety and efficacy of investigational products and/or medical devices.
Essential Functions:
- Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required.- Generates, tracks and resolves data clarifications and queries. May implement CRF design in identified graphic design package.- Reviews data listings for accuracy and consistency of data. Analyzes and resolves data validation and other data management reports.- Produces project-specific status reports for CDM management and for clients on a regular basis.- Performs data management activities such as Serious Adverse Event and Third-Party Vendor reconciliations as well as Data Listing reviews.
Education/Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills & Abilities:
- Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations- Strong attention to detail and skill with numbers and ability to use interactive computer programs- Good written and verbal communication skills and a strong command of English language and grammar- Good organizational and analytical/problem-solving skills- Ability to work productively with moderate supervision- Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data- Strong customer focus and excellent interpersonal skills.- Proven flexibility, adaptability and ability to work in a team environment or independently as needed- Must demonstrate good judgment in making decisions- Knowledge of medical/clinical trial terminology- Understands project protocol and Data Validation Manual
Working Environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. 10-20% annual possible.
PPD Defining Principles:
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD
This advertiser has chosen not to accept applicants from your region.
3
Clinical Data Associate Iii
Mandaluyong, National Capital Region
Syneos Health Clinical
Posted today
Job Viewed
Job Description
**Description**
**Clinical Data Associate III**
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
**Why Syneos Health**
- #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
**Job responsibilities**
- Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager and/or Biometrics Project Manager as necessary.
- Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).
- Creates and enters test data for User Acceptance Testing (UAT)
- Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices.
- Receives and enters lab normal ranges.
- Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets.
- Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the Data Validation Specification and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries and re-queries where appropriate.
- For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly. Submits copies of the DCFs to sponsors as necessary.
- For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies.
- For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.
- For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable electronic data capture (EDC) systems.
- Creates electronic storage media per SOPs for EDC studies.
- Participates in internal meetings and internal/external audits as required.
- Files documentation in the Data Management Study File (DMSF).
- Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College).
- Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs.
- Coordinates the work of CDAs assigned to the project.
- Provides training on data management activities and systems.
- Provides project-specific training to other Clinical Data Associates (CDAs).
- Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party.
- Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries.
- Runs data cleaning and/or status reports.
- Performs Serious Adverse Event (SAE) reconciliations.
- Performs peer review to other CDAs and provides feedback.
- Understand how data management i
**Clinical Data Associate III**
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
**Why Syneos Health**
- #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
**Job responsibilities**
- Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager and/or Biometrics Project Manager as necessary.
- Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).
- Creates and enters test data for User Acceptance Testing (UAT)
- Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices.
- Receives and enters lab normal ranges.
- Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets.
- Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the Data Validation Specification and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries and re-queries where appropriate.
- For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly. Submits copies of the DCFs to sponsors as necessary.
- For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies.
- For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.
- For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable electronic data capture (EDC) systems.
- Creates electronic storage media per SOPs for EDC studies.
- Participates in internal meetings and internal/external audits as required.
- Files documentation in the Data Management Study File (DMSF).
- Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College).
- Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs.
- Coordinates the work of CDAs assigned to the project.
- Provides training on data management activities and systems.
- Provides project-specific training to other Clinical Data Associates (CDAs).
- Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party.
- Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries.
- Runs data cleaning and/or status reports.
- Performs Serious Adverse Event (SAE) reconciliations.
- Performs peer review to other CDAs and provides feedback.
- Understand how data management i
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