YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Manager, Clinical Data Management, are to: 

• Serve as the key subject matter expert on topics related to data management activities including specific activities and processes in early clinical development phases, including vendor selection and management, mentoring junior staff, training team members, leading or contributing to expert working groups (e.g., QSD initiatives), 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 projects;
• Assume ownership of development and maintenance of Medical Standards relevant to the area of responsibility;
• Contribute to the definition of data structure standards;
• Review applied results of the Important Medical Event (IME) List and medical coding conventions;
• Ensure adequate application of Data Management Best Practices across studies within assigned projects;
• Review Study Team documents for project consistency;
• Ensure the adequate documentation of all data management activities according to SOP’s;
• Incorporate and maintain Medical Standards in clinical studies and projects for all elements of the medical standards package;
• Provide governance and 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, definition of deliverables, Bayer-internal QC measures, progress tracking and application of best data management practices;
• Advise on resource planning/allocation based on forecasted clinical activities per the Clinical Development Plan (CDP) and actual study/project metrics;
• Ensure smooth phase-transitioning of projects between research and development phases within P&O;
• Organize state-of-the-art support for data-driven processes of interfacing business functions like Pharmacovigilance department, Pharmacokinetic department, Pharmacometrics department and others by ensuring timely and high quality Data Management input;
• Support actively assessment of future trends to prepare for the future, including personalized medicine, evidence based re-imbursement, smart data storage, data insights, predictive and probabilistic data management methods, digital studies, wearable devices;
• Assume operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies and apply Data Management best practices;
• Be accountable or a contributor for CDM deliverables from protocol creation until release of data for analysis;
• Ensure CDM input and contributions to Risk Management (risk identification, risk communication, incorporation of risk in risk management plan, implementation of risk mitigation activities in relevant plans);
• Incorporate and maintain Medical Standards in clinical studies 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, including initiating the documentation, maintaining document management systems, coordinating and ensuring contributions from relevant functions, requesting a timely QC of the documentation, 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, 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., Project Plan, Data Management Plan, Operational Oversight Plan, etc.) to ensure proper governance of data management study set-up, conduct and closure activities;
• Be 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 important deviations and validity findings, planning and conduct of interim and final Blind;
• Review Meeting, preparation and completion of the final Blind Review Report;
• Engage actively in ongoing data review/reconciliation activities and utilize dashboards, metrics and patient trackers to monitor data arrival and clean up;
• Share data arrival and cleanup status and metrics with the Study Team;
• Plan and track data contributions of specialized functions typically used for early clinical development activities like Pharmacokinetics, Biomarker, Bioinformatics, Pharmacometrics, as well as strategic operational partners;
• Establish data management best practices for data generated in relevant research activities which may be needed in later project activities like decision making processes and submissions, including support of setting data standards compatible with Bayer development standards, support of central storage and inventory, supporting data transfer activities from external vendors, supporting integration with data generated in clinical phases of development;
• 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 and track query status;
• Contribute to projects and initiatives aimed at improving and optimizing the delivery of DMAR, DS&A, Portfolio and Operations, OSBU;
• 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 SOP;
• Be responsible for the consistency in support, planning and delivery of data management deliverables in assigned studies, projects (if applicable) or research activities;
• Contribute to the development and sharing of best DM practices, these efforts cascade throughout the supported research and drug development value chain.
   

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 or equivalent/higher;
• At least five years of study and/or project level experience as a Data Manager in supportive and leading roles or as a project-leading role in a scientific, data-driven position in the medical research area;
• At least two years of experience should demonstrate full responsibility as a Study Data Manager, or equivalent roles in in a scientific data driven position in the medical research area;
• Enough knowledge of clinical research/development operations in order to execute relevant data management activities independently;
• Lead a CDM team, and professionally contribute to project level activities;
• Good understanding of the drug development process, understanding of relevant research processes;
• Strong organizational skills and able to collaborate with minimal supervision;
• Ability to work effectively in a global environment;
• Customer focus, drives results, plans and aligns;
• Instills trust and manages complexity should be also displayed by the incumbent;
• Significant experience in using data management methodologies and technologies (e.g. Electronic Data Capture Familiar with data warehousing, and working in a SAS environment);
• Demonstrated understanding of regulations and guidelines (e.g. ICH, GCP, European Clinical Trials Directive, Privacy rules [HIPPA]);
• Conduct him/herself in an appropriate business manner adhering to a high ethical standard.

Preferred Qualifications:

• Degree in the fields of Natural Sciences or Life Sciences.