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Principal Data Manager

Principal Data Manager
Company Work Location: Whippany, NJ

Responsibility:
Design high quality CRFs in consultation with a cross functional team that accurately reflect the data collection requirements identified in the study protocol and that are consistent with internal standards.
Assist with database design to ensure it meets requirements for the entry and reporting of clinical data.
Develop CRF Completion Instructions to serve as an aid for site personnel to complete the CRFs.
Define Edit Check specifications and work with Database Programmers to ensure accurate and timely programming.
Develop Data Management Plan.
Perform User Acceptance Testing to ensure the quality and integrity of the clinical study database design and associated edit check programming prior to the study database being released to collect data.
Conduct data review and associated query generation/resolution.
Perform Database Finalization activities and deliver quality results within agreed upon project timelines.
Identify issues, define and direct resolution measures; reports progress and escalate issues into management.
Represents GDM as the Core Study Team member for internal and outsourced studies, and coordinates the SDM Team in any aspect.
Manages cross-functional team memberships and interfaces effectively: serves as GDM member of the core Global Clinical Team;
Works closely with clinical and safety experts in the definition, preparation and review of reports that are critical to ensuring the quality, accuracy and completeness of analyses on study safety, medical coding and Global Pharmacovigilance data.
Develops robust and productive relationships with internal and external business partners: treats others fairly and with respect; manage conflicts constructively; provide timely and relevant feedback.
Requirements:
Bachelor's degree (or equivalent) in natural sciences, informatics or medical documentation
At least 7 years of study and/or project level experience as a Data Manager in supportive and leading roles.
At least 2 years of experience should demonstrate responsibility as the DM lead on studies/project(s).Deep understanding of the drug development process
Strong organizational skills and able to collaborate with minimal supervision.

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