Available Positions

Principal Data Manager at Pharmaceutical Company in Ridgewood, New Jersey, United States —

  • Pharmaceutical
  • Pharmaceutical Company
  • Ridgewood, New Jersey, United States
  • 5/23/19

Job ID: 35023

Job Description

Serve as the key subject matter expert on topics related to data management

Review Study Team documents for project consistency

Support proactive DM specific project planning and tracking of assigned projects

Advise on resource planning/allocation based on forecasted clinical activities

Support implementation of Biomarker strategy for projects and studies

Organize the Pharmacokinetic processes across all phases

Translate relevant research data into early clinical development in co-operation with the involved research and development functions

Specify and develop study specific eCRFs, database structures and data

Contribute to projects and initiatives aimed at improving and optimizing the delivery of GCDM CDMCS, GCDM and GDSA services

Perform duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards

 

*MO25 

Qualifications

Bachelor’s degree or higher

7+ years of study and/or project level experience as a Data Manager in supportive and leading roles

2+ years’ experience in early clinical development essential

Experience in Therapeutic Areas matching those of Bayer’s research and development activities preferred

Understanding of the drug development process and relevant research processes

Strong organizational skills and able to collaborate with minimal supervision

Basic SAS Programming knowledge, or other database experience

Demonstrated understanding of regulations and guidelines 

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