Passage Bio is currently seeking a Director of Data Management to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects.
The Director will be responsible for planning, implementing and managing Data Management (DM) activities across trials and programs, including but not limited to database and technology selections, vendor management, data collection and review, project timelines and budgets and ensuring quality standards maintained. The Director is also responsible for leading or contributing to company process improvement initiatives. This position reports to the VP of Clinical Operations.
Key duties include:
- Study database design, database structure, document creation
- Responsible for the oversight of DM vendors for assigned trials to ensure data quality, integrity and timeliness
- Provides DM expertise to database set up, CRF design, and data cleaning activities
- Ensures clinical data within EDC is of a quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock
- Coordinates and performs review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy
- Responsible for building effective DM vendor relationships. This includes being involved in RFP development, contract negotiation and selection of DM and/or technology, as needed.
- Works closely with CROs to prepare and ensure proper execution documents such as CRFs, data management plans, dataset transfer standards, WHO Drug and MedDRA coding standards, manual review plans, line listing review plans, and data validation plans
- Ensures clinical databases and external data files are designed in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and a possible regulatory submission
- Develops, maintains and implements Passage Bio DM standards
- Ensures data management activities are conducted in accordance with GCP, GCMP, internal SOPs and meet all regulatory requirements
- Leads and/or contributes to department initiatives and assists in the design and implementation of standardized work processes.
- Manage project quality through supervision and quality control of Passage Bio and partner vendor team member
- Regularly reports to management and leadership on status of program, risks, accomplishments, schedule, and budget
- Bachelor’s degree in scientific, healthcare, biological, statistical, computer science, or related field is required.
- 7+ years of clinical trial data management experience for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
- Thorough knowledge of clinical data management and its role in the drug development process
- Understanding of the contributions of other functions critical to the execution of clinical trials, and their interactions with clinical data management
- Experience of all stages of a clinical trial and vendor oversight
- Demonstrated knowledge of ICH/GCP guidelines as they relate to clinical data management
- Thorough understanding of CDISC CDASH and SDTM standards
- Extensive experience managing CROs and other data vendors
- Ability to work on and solve complex problems
- Ability to prioritize and handle multiple tasks simultaneously
- Excellent communication/interaction skills and experience in a dynamic and growing organization.