Associate Protocol Data Manager
About the Job
Data Management, which is part of Global Clinical Operations, is accountable for the verification, validation and quality control of data gathered (both external and clinical) during the conduct of Phase I-IV clinical trials. The data collected forms the basis of subsequent safety and efficacy analysis and must adhere to regulatory requirements and guidance.
- Understands the importance of data quality and ensures data quality drives all data management related activities for the protocol. Contributes to the data quality of the protocol by taking responsibility for specific tasks outlined in the policies and procedures documents, as well as by adhering to process flows and task lists.
- 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. Supports review of Case Report Form (eCRFs), database and Data Review Plans that have relevance to external and clinical data collection to ensure they are complete, correct and adhere to BMS standards.
- Assists with study level data management activities for assigned protocols (e.g. data management metric tracking, reviewing data listings and tables, monitoring query flow and receipt of external data, overseeing discrepancy management). Answers and resolves routine data related questions.
- Assists with identifying and resolving data management issues which impact timelines. Communicates and resolves data issues with vendor staff and Clinical Team as appropriate. Uses appropriate escalation pathway to inform the appropriate team members of problems and potential solutions. Engages the PDM to assist in the resolution of more complex issues. Has a basic understanding of how the issues for a single study can impact the overall project.
- Manages matrix relationships with other study team members. Provides feedback and status updates to protocol team members on an as needed basis. Proactively identifies and presents data related issues to PDM and team members to help ensure data management activities are in compliance with required standards (i.e. global and program level standards, ICH-GCP guidelines, BMS SOPs and regulatory guidelines or regulations).
- Assists in the development of training material and supports the initial or ongoing data related training of Investigators, site personnel, vendors, BMS team, etc, for data related issues. Collaborates with other PDMs and the study team to help ensure training is consistent across all protocols within a program.
- Contributes to the establishment and/or development of best practices through coaching and feedback. Helps ensure best practices are shared and common issues communicated to PDMs to support consistency within a protocol or program and/or role.
- Skilled in the use of technology (e.g. OC, JReview), is able to function with limited supervision within an environment that relies heavily on this knowledge for status information, issue resolution, and communication.
- Effectively uses available tools to gather information needed to manage study activities, to write and/or generate reports, and to provide feedback to the PDMs or appropriate study team members.
- Supports PDM with defining data review components necessary to conduct a clinical trial. Assists the PDM during the data review strategy process to help optimize the cleaning and review process and help ensure program level standards are applied at the protocol level from study start-up to database lock.
- Assist with writing the validation specifications as well as support the testing of validations and derivations to ensure that they work as intended.
- Possesses knowledge and understanding of Clinical Study Report concepts and applies them during the development of the data review cleaning and review strategy. Supports the development of data review and data review strategy plans.
- Supports the completion of all database lock activities to the standards expected. Communicates to PDM and/or appropriate study team members any identified risks (e.g. outstanding SAE queries, delays in external files) to time lines and deliverables, and suggests contingency plans if appropriate. Assists with resolving issues arising at time of database lock helping to ensure critical milestones are met.
- Participate as an active Associate PDM representative in cross functional teams.
- Adheres to policies and practices as specified around masked data in clinical trial.
Bachelor’s degree preferred in one or more of the following disciplines or related fields\: Clinical Pharmacology; Life Sciences; Laboratory Sciences; Allied Health; Pharmacy; Nursing; Computer Science; Business/Information Systems.
3 years of related experience.
Experience negotiating with and influencing others to meet challenging goals. Must be self-motivated, with the ability to follow through on assignments without direct supervision, very attentive to detail, capable at multitasking across projects and able to effectively contribute in a team environment.
Strong analytical skills to facilitate detecting and resolving data problems encountered in clinical research studies.
Knowledge of data review processes and Database Management Systems including eDC systems a plus.
Knowledge of general clinical research including Investigator site processes.
Knowledge of the pharmaceutical industry including the clinical and regulatory components.
Knowledge of basic project planning and management methods.
Software that must be used independently and without assistance (e.g., Microsoft Suite). Basic office tools (e.g. MS Suite); CDMS (e.g. Medidata Rave); JReview a plus.