Your tasks and responsibilities
The primary responsibilities of this role, Senior Data Lead Manager, are to:
Who you are
- 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 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); provide data structure standards; review application of the Important Medical Event (IME) List, medical coding conventions, and standard coding rules;
- 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;
- 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;
- Advise on resource planning/allocation based on forecasted activities per the Clinical Development Plan and actual study/project metrics;
- Assume operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and apply Data management best practices;
- Incorporate and maintain Bayer standards in clinical studies and projects for all elements of the medical standards package;
- Document all activities adequately for all assigned studies according to SOPs and takes a lead role in QC activities, which includes, but is not limited to: initiating the SDMD, maintaining document management systems, coordinating and ensuring contributions from relevant functions (i.e., EDC, CDC, etc.), requesting a timely QC of the SDMD, informing relevant functions of results and ensuring proper communication between functions, QC manager and self so that all issues are reconciled;
- Specify and develop study specific eCRFs, database structures and data consistency checks based on medical standards, the Clinical Study Protocol and input from the study team;
- Prepare, track, and implement standard plans (i.e., GDM Study Plan, Data Management Plan, Operational Oversight Plan, etc.) to ensure proper governance of data management study set-up, conduct and closure activities;
- Accountable for data management activities necessary for the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of protocol deviations, planning and conduct of interim and final Validity Review Meetings, preparation and completion of the final Validity Review Report;
- Support study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions;
- Identify and issue queries, incorporate query replies, track query status and apply permissible clarifications using the EDC and related systems;
- Contribute to projects 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).
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:
- Bachelors' degree or equivalent in Natural Sciences, Informatics, or Medical Documentation;
- 5 years of study and/or project level experience as a Data Manager in supportive and leading roles and 2 of those years should demonstrate responsibility as a study leader;
- Knowledge of the drug development process;
- Strong organizational skills;
- Able to collaborate with minimal supervision;
- Significant experience in using data management methdologies 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);
- Conduct yourself in an appropriate business manner adhering to a high ethical standard.
- Basic SAS Programming knowledge or other database experience.
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.
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. Country:
United States Location:
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Why Bayer? Because we’re a pioneer in the fields of human, animal, and plant health. Because we invent solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.