Clinical Data Reviewer (CDR)
About the Job
Purpose/Objective of the job\:
To perform protocol level clinical data review and cleaning activities to support clinical trials and maintain protocol data quality
Key Responsibilities and Major Duties\:
- Responsible for clinical data listing review at protocol level to ensure data submitted by investigative sites is of high quality and completed within predefined study timelines.
- Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning.
- Demonstrates an understanding of the indication studied and the overall clinical data review goals in meeting the objectives of the protocol. Works closely with other protocol team members to meet the appropriate timelines for data cleaning requirements at the site/protocol level
- Responsible for the identification and resolution of issues noted during clinical data listing review. Engages the Protocol Data Manager to assist in the resolution of database related issues and/or the Lead Clinical Data Reviewer for more complex clinical issues
- Understands how data related issues can impact analysis and reporting and applies the escalation path appropriately
- Proactively collaborates with other study team members to address issues related to data quality at worldwide level.
- Effectively uses available tools and systems to gather information needed to manage clinical data listing review, generate reports and to provide feedback to the appropriate BMS team members.
- Main point of contact with the site facing role in the clinical data review process
- Contributes to non-project task forces, work streams and initiatives.
(Disclaimer\: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Key Stakeholders/Contacts – describe this position’s key internal matrix relationships and key external stakeholders/clients
- Will be integrated in the stakeholder engagement document of the department
BMS Job Profile
- Manager/Associate Director CDR
List of minimum requirements
- Bachelor’s degree (preferably in Life Sciences, Allied Health, Pharmacy, Nursing) and/or clinically related experience in Life Sciences, Allied Health Pharmacy, Nursing or equivalent field.
Experience – Responsibility and minimum number of years
- 4 to 6 years of experience in clinical data review or similar industry roles involved in data review/management
- Experience in clinical trials
- Experience preferred in clinical data listing review and the use of data review tools
- Experience preferred in drug discovery / development process
- Demonstrated success in using oral and written communication skills to convey information and influence, inform, train and/or guide others
- Experience working in a team environment, preferably within a matrix organization
- Experience in effective implementation of data review/management plans/documents preferred
Competencies – knowledge, skills, abilities, other
- Basic knowledge of data review process and awareness of associated systems and tools
- Knowledge of general clinical research including investigator site issues, important milestones and strategies to ensure timelines are met.
- Basic understanding of project planning/management
- Knowledge of techniques used to lead effective meetings and the use of presentations to communicate plans.
- Attention to detail and accuracy
- Skilled in the use of technology
- Ability to function independently
Software that must be used independently and without assistance (e.g., Microsoft Suite)
- Basic office tools (e.g. MS Suite);
- BMS tools (e.g. mylife@”BMS, Success Factors Learning);
- In-depth knowledge of software/applications that support clinical data review.
BMS BioPharma Behaviors Required
Travel Required (nature and frequency)
- Some travel for meetings, training courses, inter-site travel to meet with colleagues
Overnight Absences Required (per typical month)
- Depending on business need
Describe exposure to any hazards/disagreeable conditions in the work environment