Principal Data Manager
Your tasks and responsibilities
The primary responsibilities of this role, Principal Data Manager, are to:
- Serve as the key subject matter expert on topics related to data management activities; Contributions include, but are not limited: vendor selection and management, mentoring junior staff, training team members, leading or contributing to expert working groups (e.g., SOPs, OM's, PGDs, etc.), presenting best practices at internal and external industry meetings meetings/congresses, and participating in due diligence assessments;
- Govern the use of key data management elements across studies in assigned project: assume ownership of development and maintenance Medical Standards relevant to the area of responsibility (GMS/TAS/CPS/Codelists), provide data structure standards, review application of the Important Medical Event (IME) List, medical coding conventions, and standard coding rules;
- Ensure adequate application of Data Management Best Practices across studies within assigned project: review Study Team documents for project consistency and ensure the adequate documentation of all data management activities according to SOPs;
- Provide oversight for outsourcing activities by providing input on budgetary items (e.g. RFP, vendor costing, synergies, change orders, etc.), vendor selection and management, risk and communication management, and application of best data management practices;
- Advise on resource planning/allocation based on forecasted activities per the Clinical Development Plan and actual study/project metrics and initiatives aimed at improving and optimizing the delivery of Project and Study Data Management, GDM and GCO services;
- Perform duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards;
- Ensure complete, accurate and timely documentation for all projects/studies according to established SOPs, Operational Instructions (OIs) and Process Guidance Documents (PGDs).
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Bachelor’s Degree
- Seven years of study and/or project level experience as a Data Manager in supportive and leading roles; At least two years of experience should demonstrate responsibility as the DM lead on studies/project(s);
- Detail oriented with one or many expertise in data management;
- Ability to lead a study or project data management team independently;
- Capable of contributing to and/or lead projects to improve best practices;
- Deep understanding of the drug development process;
- Strong organizational skills and able to collaborate with minimal supervision;
- Basic SAS Programming knowledge or other database experience.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.