Lead Clinical Data Reviewer
About the Job
Description: Purpose/Objective of the job\: To perform protocol level clinical data review and cleaning activities to support clinical trials and maintain protocol data quality. Provides leadership and guidance to protocol CDRs to ensure execution of data review deliverables.
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.
- Implements clinical data review strategy to meet needs of protocol and ensure alignment with program level standards.
- Demonstrates an understanding of the indication studied and the overall clinical data review goals in meeting the analysis and reporting 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.
- Performs protocol level clinical data listing review, including more complicated protocol/TA listing review. Understands the protocol in detail. Works in conjunction with PDM to develop new/protocol specific data review tools; understands the analysis and reporting needs of the protocol.
- Provides clinical data review oversight of the protocol(s). Manages protocol clinical data review priorities within assigned protocols and in accordance with functional area processes.
- Ensures there is consistency/accuracy in data review within the assigned protocols.
- Supports and contributes to the development and embedding of new processes.
- Responsible for identifying and follow-up to ensure resolution of data related issues noted during clinical data listing review. Escalates to the appropriate BMS team members, suggests solutions and coordinates follow-up.
- 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, generates reports and provides feedback to the appropriate BMS team members.
- Serves as key point of contact to protocol team to address issues related to data quality at worldwide level.
- Provides Protocol and/or Program specific data cleaning and review guidance to the team.
- Accountable for facilitating the tracking, and monitoring the progress, of data review activities with protocol CDR team.
- Collaborates with other Lead CDRs to establish best practices to ensure consistency across program and/or indication in data cleaning requirements.
- Effectively drives or contributes to non-project taskforces, business work streams, and initiatives. Promotes sharing of best practices and lessons learned.
- Empowers team to achieve high performance and excellence. Holds self and others accountable for decisions and results achieved. Acts with integrity and models ethical behavior.
Supervisory Responsibility (List job titles of positions that report directly or indirectly to this position and indicate nature of relationship)
- No direct line management, but will lead indication and protocol level data review involving multiple CDRs.
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
- 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
- 5 to 7 years of experience in clinical data review and using eDC systems or similar roles in the industry related to data management/review.
- Experience in drug discovery / development process.
- Demonstrated success in using oral and written communication skills to convey information and influence, inform, provide training and/or guide others.
- Experience working in a team environment within a matrix organization.
- Expertise in clinical trial conduct and protocol clinical data listing review and the use of data review tools
- Experience in effective implementation of data review/management plans/documents and document preparation.
- Experience in reviewing documents (e.g. Study protocol, eCRF instruction, Data review and Cleaning Reports Listings).
- Previous experience using project management techniques including prioritization methods.
- Capable of independent decision making to meet program/protocol objectives, when needed.
- Previous experience working with projects that require accuracy and special attention to details.
Competencies – knowledge, skills, abilities, other
- Knowledge of data review process and Database Management Systems including eDC systems.
- Demonstrates a strong understanding of clinical safety and efficacy data.
- Knowledge of ICH-GCP guidelines and regulatory regulations. Knowledge of Statistical Analysis and Data Presentation Plans desired
- Knowledge of general clinical research including investigator site issues, important milestones and strategies to ensure timelines are met.
- Demonstrates a strong understanding of the overall project goals, the indication studied and the purpose of the assigned study in meeting the objectives of the project. Be able to understand clinical data in different disease areas, become familiar with the disease under study and the study endpoints.
- 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.
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 - NA