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Principal Data Manager

.pre {white-space: pre-wrap;} 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 (standard operating procedures), OM's (operating manuals), PGDs (progressive guidance documents), 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: assumes ownership of development and maintenance Medical Standards relevant to the area of responsibility (GMS (Global Medical Standards)/TAS (Therapy Area Standards)/CPS (Clinical Project Standards)/Codelists); provides 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; 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;
  • 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;
  • Support thedevelopment and implementation of Project and Study Data;
  • Contribute to projects and initiatives aimed at improving and optimizing the delivery of Project and Study Data Management, GDM (Global Data Management) and GCO (Global Clinical Operations) 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).

 

.pre {white-space: pre-wrap;} 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:

 

Required Qualifications:

 

  • Bachelor’s Degree required;
  • At least seven (7) years of study and/or project level experience as a Data Manager in supportive and leading roles, at least two (2) years of experience should demonstrate responsibility as the Data Management lead on studies/projects;
  • Deep understanding of the drug development process;
  • Strong organizational skills and able to collaborate with minimal supervision.

 

.pre {white-space: pre-wrap;} Your application Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.