Clinical Trial Services Manager (Data Management) - Apogee Clinical Inc

Position Description

CTSM for project management with a clinical data management focus for a global biotechnology company based in the San Francisco East Bay.

Work in an environment; where performance is recognized and career progression is supported; where open communications that allows for differing and challenging opinions are encouraged and where a strong work-life balance is a reality.

Relocation support and a competitive compensation package are offered.

Job Description:
•Project manager and primary interface between Data Management, Clinical Operations and Biometrics for the production and implementation of clinical databases, reporting requirements, as well as post production change management to maintain high data quality.

•Collaborate with various departments on the design, documentation, testing and implementation of clinical data studies. Perform user training and user support, and support compliance activities.

•Organize and coordinate study preparation meetings involving departments relevant to the clinical trial process.

•Identify, evaluate, recommend, implement and manage clinical information technology solutions to support clinical study database and information activities.

•Cultivate and maintain interdisciplinary relationships, especially with counterparts in other divisions, to maximize efficiency and promote organizational synergy.

•Coordinate and drive collection of user requirements for construction and implementation of databases in support of clinical trials.

•Support performance qualification and user acceptance testing.

•Develop systems for regulatory compliance and the identification of trends associated with the Divisional Clinical System.

•Coordinate study change management from startup through the analysis stage of clinical studies with the support of the clinical therapeutic areas, Clinical Data Management and Biostatistics to effectively manage data capture and review activities.

•Analyze the inter-relationships of data and defines logical aspects of data sets. May evaluate and resolve issues regarding contents of reports.

Educational and Other Requirements:
•B.S. degree in a scientific or related discipline (Life Sciences, Computer Science, Bioinformatics), higher degree preferred
•5-8 years of experience in the design, management, analysis and reporting of pharmaceutical or medical device clinical study results
•4 years of leadership role in a Clinical Information Technology and Programming environment
•Experience in the support and project management of global clinical trials as well as CRO management preferred
•Knowledge of regulatory requirements pertaining to clinical data systems
•Excellent organizational, communication, negotiation, and interpersonal skills. Experience in dealing with ambiguity, working across culture, and dealing with conflict
•Experience with Clinical Information Management systems (Oracle Clinical, Clintrial, eRT, eTrials, Phase Forward)
•Experience in the definition and implementation of electronic systems used in clinical studies (electronic data capture, trial management, document management, and project management systems)

How to Apply

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