Technical Project Manager, Clinical Data Integration - Hybrid
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Job Description
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
The Technical Project Manager is responsible for the oversight and management of the end-to-end delivery of technical data management components for one or more drug/vaccine programs. Provides technical consultation on the data management strategy, collaborates with appropriate functional areas to secure and align resources, and ensures all aspects of the technical project plan for in-scope studies are executed on time and with quality. Supports less experienced Technical PMs in the development of project plans which span from design and specification development through production deployment and subsequent change management support.
Minimum education required:
B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.
Required experience and skills:
A minimum of 3 years of experience working with formal project management tools and processes.
In-depth knowledge of the clinical development process, preferably through submission.
Thorough knowledge of clinical data management; demonstrated knowledge of technical processes inclusive of electronic Case Report Form (eCRF) development, clinical database development, data validation tool development, user acceptance testing, data integration from different sources, data flow/migration, and application of CDASH and SDTM standards is preferred.
Experience using project management tools such as Microsoft Project.
Demonstrated leadership and project management skills, strong organization, communication, negotiation, and problem-solving skills. Strong customer-focus and interacts effectively with different functional groups.
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