Principal Data Manager
Your tasks and responsibilities
The primary responsibilities of this role, Principal Data Manager, are to:
- Tracks and leads project-level data management activities: manage PDM Teams efficiently; ensures the timely delivery of high-quality study databases and smooth operation of SDM teams; 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.
- Serves 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.
- Governs 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/TAS/CPS/Codelists); provides data structure standards; review application of the Important Medical Event (IME) List, medical coding conventions, and standard coding rules.
- Ensures 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.
- Provides 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.
- Advises on resource planning/allocation based on forecasted activities per the Clinical Development Plan and actual study/project metrics.
- Supports the development and implementation of Project and Study Data Management strategic initiatives and activities.
- Contributes to projects and initiatives aimed at improving and optimizing the delivery of Project and Study Data Management, GDM and GCO services.
- Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards.
- Ensures complete, accurate and timely documentation for all projects/studies according to established SOPs, Operational Instructions (OIs) and Process Guidance Documents (PGDs)
Who are you
Your success will be driven by your demonstrations of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possess the following:
Who you are
- 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
- Basic SAS Programming knowledge, or other database experience, preferred
- Significant experience of using data management methodologies and technologies (e.g. data warehousing, electronic data capture)
- Demonstrated understanding of regulations and guidelines (e.g. ICH, GCP, European Clinical Trials Directive, Privacy rules [HIPPA])
- The incumbent is required to conduct him/herself in an appropriate business manner adhering to a high ethical standard
Bayer welcomes and encourages applications from people with disabilities. Candidates participating in our selection process requiring accommodation due to a disability or medical need are encouraged to notify the Bayer representative that they will be meeting with to ensure appropriate arrangements can be made.
Location: Mississauga, Toronto
Functional Area: [sap_fa_28]
Entry Level: 5