South San Francisco, CA
|Job Title: Principal Clinical Data Manager, Clinical Data Management||Download
Department: Clinical Data Management
Job Title: Principal Clinical Data Manager, Clinical Data Management
Reports to: Associate Director/Director, Clinical Data Management
Primary Objective of Position
The 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
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.
- Detail oriented and self-motivator
- Familiarity in Microsoft Office Products
- Excellent listening and communication skills, with an ability to accept direction and feedback
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
- 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
- Knowledge of Oncology clinical trials
- Nursing background
- Vendor management experience
- Familiarity with SAS
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Puma Biotechnology, Inc.
10880 Wilshire Blvd., Suite 2150
Los Angeles, CA 90024
Stacey Willard, Recruiting Manager