Principal Clinical Data Manager
Your tasks and responsibilities
Assumes ownership and leadership for all Clinical Data Management owneddeliverables within assigned compound, projects and studies andprovides leadership to respective CDM staff, interfacing functions andteams in order to support and achieve defined business goals.
Serves as the key subject matter expert on topics related to data management activities including specific activities and processes in early clinical development phases. Contributions include, but are not limited to: 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.
Governs use of key data management elements across studies in assigned projects: assumes ownership of development and maintenance Medical Standards relevant to the area of responsibility; contributes to data structure standards; review results of applied Important Medical Event (IME) List, medical coding conventions. Accountable or a contributor for CDM deliverables on study and/or project level.
Ensures 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 SOPs.
Provides 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.
Advises on resource planning/allocation based on forecasted
activities per the Clinical Development Plan (CDP) and actual
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).
Proactive DM specific project planning and tracking (timelines, budget, risk assessment) of assigned projects from D3 to PoC and/or to submission, fully aligned with the Statistics function (2-Lead model) and the corresponding activities of the Early Clinical Team and Clinical Project Team.
Ensures smooth phase-transitioning of projects between research and development phases in P&O, is instrumental to facilitate data access and exchange between research and development functions.
Organizes 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. Establishes data management best practices for data generated in relevant research activities.
Actively supports 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.
Engages actively in ongoing data review/reconciliation activities and utilizes dashboards, metrics and patient trackers to monitor data arrival and clean up. Shares data arrival and cleanup status and metrics with the Study Team.
Supports the development and implementation of DMAR and/or OSBU DM strategic initiatives and activities. Contributes to projects and initiatives aimed at improving andoptimizing the delivery of DMAR. DS&A, Portfolio & Operations, OSBU.
Functional Area: [sap_fa_28]
Entry Level: 5