THIS IS A REGULAR FULL TIME ROLE THAT INCLUDES FULL BENEFITS PACKAGE, BONUS POTENTIAL AND POSSIBLE STOCK OPTION
THIS ROLE IN ONSITE AT THE CLIENT OFFICES IN EITHER WEST LA OR SOUTH SF
NO REMOTE OR TELECOMMUTE OPTION FOR THIS ROLE
Primary Objective of Position
Principal Clinical Data Manager, Clinical Data Management, is responsible for leading study data management activities including, but not limited to, coordination of CRF design, development, review and sign off ; Reviews and approves CRO generated Data Management documents, coordinates database live and close out activities with the CRO, provides guidance to CRO to manage query flow and implements quality control plan. The individual may participate in reviewing vendor audit plan and statistical analysis plan as needed; may participate in vendor qualification and selection as appropriate, and participates in monitoring vendor performance
Major Duties/Responsibilities
Reviews listings to identify data discrepancies and tracks resolutions
Works with Study team to design mock CRFs based on the protocol
Leads database design, implementation and testing activities
Supervises all Data Management deliverables and associated timelines with the CRO to ensure a quality database lock
Co-ordinates with Clinical Operations, Biostatistics, Statistical Programming, Safety and other departments, as needed, to resolve data issues
Skills & Abilities
Excellent organizational skills and ability to prioritize tasks
Must be able to work under tight timelines
Possess excellent communication skills
Anticipates change and reacts quickly and intelligently to accommodate business needs.
Physical Demands
The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.
The physical demands of the office are normally associated with extended amounts of time in front of a computer. While performing the duties of this job, the employee is frequently required to stand, walk, and sit. May involve travel up to 10%
Education & Professional Experience
Required:
Bachelor’s Degree in a biological sciences or other medically related areas
Minimum of 7 years of data management experience in the biotechnology/pharmaceutical industry
Familiarity with data management software (e.g. Medidata, Oracle Clinical)
Working knowledge of coding dictionaries – MeDDRA and WHODRUG
Preferred:
Knowledge of Oncology clinical trials
Nursing background
Vendor management experience
Familiarity with SAS