Overview
NOTE: The title of this position depends on the discretion of the hiring manager.
SUMMARY OF KEY RESPONSIBILITIES
- Creates forms specifications (electronic CRF design and other forms, as required), writes and tests data validation specifications; writes eCRF completion guidelines and performs quality review of data in collaboration with CRO partner’s data management.
- Works with data management service providers and is responsible for overseeing database audits, clinical coding, SAE/AE reconciliation, integrated data review and database lock.
- Provides support in the form of data listing review (blinded TLFs) and Sr. Management Team support for Data Management Committee (DMC) meetings.
- Provides project management of the clinical trial in collaboration with Global Project Manager to provide oversight to the data management component of CRO responsibilities.
- Writes SOPs for data management, as needed.
- Develops standard vendor assessment for vendors, providing data management services including EDC systems.
- Plans and tracks relevant milestones and produces key project progress reports (DMC timelines, TLF review and finalization, etc.).
- Participates in RFI, RFP generation, vendor selection and contract oversight with all vendors involved in aspects of data management.
- Works with other Project Managers and functional area managers to ensure consistent operations and use of best practices; serves on teams to optimize processes and use of technology.
- Ensures validity of clinical data, defines and tests automated validation checks and defines data review guidelines.
- Performs data review and oversees AE coding, either internally or externally (CRO).
- Acts as primary contact with clinical, programming and statistics groups to make study decisions regarding data conventions, data queries and study timelines; close collaboration with Safety and Pharmacovigilance, Regulatory Affairs and Program Management may be required.
- Attends Investigator meetings and presents data management workflow and protocol-specific CRFs and guidelines.
- Trains internal personnel and site personnel on data management issues such as EDC, query resolution, TLF review, etc.
- Assists with special projects, as needed.
REQUIRED QUALIFICATIONS AND SKILLS
- BS in a scientific field, and at least 5 years of progressive growth in data management of clinical trials; an advanced degree or RN preferred
- Proficient in Oracle Clinical, Clintrial, MS Office and SAS
- Broad experience with all aspects of data management, with at least 2 years in a lead role in the biotech, pharmaceutical or CRO arena and oversight of contracted resources
- Fundamental knowledge of GCP, FDA and ICH regulations
- Therapeutic knowledge in any of the following areas is desired: transplant, sepsis, critical care, oncology, respiratory/pulmonary or infectious diseases
- Highly self-motivated, with superior organizational, communication and management skills
- Ability to mentor, as well as build network and strategic partnerships
- Experience with vendor management
- Skilled at developing and implementing creative solutions
- Ability to work constructively and productively in a matrix environment
- Sense of urgency, accountability for self, and sound operational understanding
