Clinical Data Manager

Job Description

• Project Data Management level.

• Perform DM activities for in-house and outsourced trials: protocol review, CRF development, database set up activities, data validation process (including manual data review of listings), SAE reconciliation, managing local laboratory and external labs and database lock.

• Perform Project Management : represent DM on clinical teams, coordinate deliverables by other functions and/or CRO as necessary to achieve DM deliverables.

• Coordinate with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM,)

• Coordinate CRO data validation activities (coordinate data transfer specs, data reconciliation, query generation and resolution,

• Participate in the development and implementation of department standards and documents, and other data management, departmental activities as needed.

Qualifications

Bachelor degree or above in scientific or related field Minimum 5-7 years experience in Data Management with experience in managing projects, project teams. Experience with In-Form or other EDC software is desirable however, should have some experience in supporting Oncology studies. Must be able to work independently. Proficiency on all related regulations, GCP, and Good Clinical DM Practice. Project management skills required. Strong oral and written communication skills. - Leadership skills a must

Additional Information

Best Regards,

Anuj Mehta

973-967-3402