We are using the same JD for multiple positions

NOTE: The title of this position depends on the discretion of the hiring manager.

SUSUMMARY OF KEY RESPONSIBILITIE

• 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

IF YOU THINK THIS IS YOU APPLY NOW!