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Title:Project Data Manager
Salary:Open
Experience:8+
Location:NJ - Fairfield

Description:
Ensure global clinical data management best practices and knowledge thereof in a standardized, transparent, and efficient manner.

Responsibilities:
  • Plan, organize and supervise Data Management activities for studies allocated to local staff.
  • Assume responsibility as a partner for the planning, resourcing, and execution of relevant internal and external data management activities.
  • Act as a study data manager in assigned studies, i.e. manage Study Data Management Teams and assume operational responsibility.
  • Ensure adequate application of global clinical data management best practice for all assigned studies.
  • Ensure the adequate support of clinicians in medical.
  • Contribute to the preparation of data monitoring plans (coordinate amongst Study Teams, Global Medical Surveillance, Drug Safety Monitoring Boards, Authorities and Ethics Committees) for all assigned studies .
  • Ensure the availability of protocol deviation documents for all assigned studies.
  • Support maintenance of project and therapeutic area standards (CRFs, eCRFs, data structure, listings, edit checks, derivations, code lists, instructions for handling) and consistency in co-operation data management counterparts.
  • Negotiate and communicate above standards with counterparts in neighboring functions such as the Statistics function.
  • Ensure appropriate medical coding within studies and application of global and project standard coding rules and conventions for all assigned studies.
  • Ensure adequate documentation of all activities within the sub-function for all assigned studies.

Requirements:
  • Bachelor's Degree in a health science or Informatics, and 8 years of experience, of which 2 years were as a Study Data Manager; or equivalent.
    • Alternatively incumbent must have a Masters degree and 6 years of experience.
  • Experience in either case includes a understanding of medical terminology, disease states, encoding systems (i.e. MedDRA, WHO-DD, microorganism classification, etc.) and an understanding of regulations and guidelines (i.e. ICH, GCP, European Clinical Trials Directive, Privacy rules [HIPPA]).
  • A solid understanding of database theory and experience in using data management methodologies and technologies (e.g. data computerization, storage and retrieval methods, electronic data capture) in the set-up, conduct and closeout of clinical studies is required.
  • Working knowledge of at least one industry-relevant relational database application/CDMS (e.g., ClinTrial, Oracle Clinical, etc.) and/or EDC application is required.
  • Demonstrated use of at least one data review tool/programming language (e.g., SAS, PL/SQL, SQLPlus, iReview/jReview) for development and generation of data listings, ad hoc queries, data tabulations and status or system reports is desired.
  • Incumbent must understand information flows in clinical development.
  • Effective oral and written communication skills are essential.
  • Incumbent must possess excellent interpersonal relationship skills and be able to interact with individuals across all levels of Global Clinical Organization, Medical, Statistics, and the global community in order to successfully complete assignments.
  • Incumbent must possess proven self management skills in addition to ability to coordinate local resources.
  • Relevant experience can substitute degree requirements.

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