Reports To: SVP Clinical Research
FLSA Status: Exempt
Department: Clinical Operations
The Director of Clinical Data Management will be responsible to serve as the Head of Clinical Data Management and will provide data management leadership for all investigational and commercial products. The Director of Clinical Data Management will be responsible for managing and executing the design, testing, implementation and documentation of the clinical database build activities; collection and review of internal and external data; and the adherence to relevant processes throughout the lifecycle of clinical trials. The Director of Clinical Data Management is responsible for preserving data integrity and adhering to deadlines to achieve accurate and timely regulatory submissions and publications. This position is also responsible for oversight and management of global data management vendor(s).
- Perform day-to-day data management activities for the assigned clinical studies. If data management activities for a study are performed by a vendor, oversight of activities such as CRF development, database set-up activities, data validation process, medical coding, SAE reconciliation, training of study site personnel in CRF completion, lab data transfer specifications, and data clarification processes.
- Oversight of data review activities (cleaning activities including internal cross functional listing review, external data reconciliation and data review), ensure completion of all activities for any deliverables, and manage all activities leading to the study database lock. Where applicable, ensure consistency and data standards are followed across projects in data collection and processes.
- Provide creative and effective ways to resolve data related or system related issues using professional concepts and considering company objectives.
- Ensure Data Management activities are conducted according to applicable regulations and per the protocol.
- Oversee or execute Case Report Form and Completion Guideline development and approval.
- Oversee or develop Data Management Plan.
- Prepare the Data Transfer Agreements (DTA) or oversee the development of DTA between the Data Management CRO and the External data vendors.
- Serve as lead Clinical Data Manager on assigned clinical trials and attend clinical trial study team meetings.
- Responsible for archival of data and study specific data management documentation.
- Ability to monitor own activities and project status for successful project deliverables according to timelines.
- Requires a bachelor’s degree in a scientific discipline or equivalent.
- 8+ years as a Data Manager in a Pharmaceutical/Biotechnology company, or CRO.
- Proficient in Electronic Data Capture (EDC) systems such as Medidata Rave or other related DM systems.
- Experienced with CDISC standards (eg, CDASH, SDTM) and medical coding dictionaries (eg, MedDRA, WHO Drug).
- Good understanding of ICH, GCP and other applicable regulatory guidelines.
- Effective verbal and written communication skills.
- Capable of working on multiple projects simultaneously.