We are using the same JD for multiple positions NOTE: The title of this position depends on the discretion of the hiring manager.
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.
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
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