Principal Clinical Data Manager
Employment Type: Full-Time
The Principal Clinical Data Manager leads the execution of data management activities necessary for the generation of hypothesis and for decision making in research or development phases, and for the preparation of submission data, and required documentation, for regulatory authorities and the greater clinical research community. The Principal Clinical Data Manager is proficient in at least one area related to clinical data management, such that s/he may be considered a subject matter expert on the respective topic. The Principal Clinical Data Manager may assume the business role of a Study Data Manager (SDM) in several clinical studies. In this capacity, s/he serves as the primary contact for Data Management on the Core Study Team. The SDM leads the SDM team, which is comprised of several extended Study Team members, to ensure data management deliverables meet, or exceed, corporate and industry quality standards in a timely and cost efficient manner. This includes the co-accountability with the Statistics Lead to create, maintain and manage the Project Plan. The Principal Clinical Data Manager may also support research-driven activities, or support the handling of data provided by highly specialized functions (e.g., Pharmacokinetic data, Biomarker data) ensuring data management best practices, and the usability of the generated data in regulatory processes. The Principal Clinical Data Manager may also assume the role of a Project Data Manager (PDM) or Early Project Data Manager (EPDM). In this role, the Principal Clinical Data Manager is a key driver of medical standards implementation and maintenance at the project level as well as ensuring a consistent standards handling in the project’s studies. This critical responsibility is necessary to ensure the project data is aligned with the Clinical Development Plan. The PDM/EPDM ensures consistency across studies through close interaction with the Clinical Project Team or Early Clinical Team, mentoring/coaching of SDM(s) and overseeing the Project Data Management team. The Principal Clinical Data Manager supports proactive DM specific project planning and tracking of assigned projects from D3 to PoC or to submission.YOUR TASKS AND RESPONSIBILITIESThe primary responsibilities of this role, Principal Clinical Data Manager, are to:Data Management Expertise: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.Principal Data Manager Tasks: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;Implementing Strategy: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;Ensuring Compliance: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);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.WHO YOU AREYour 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;7 years of study and/or project level experience as a Data Manager in supportive and leading roles;2 years of experience should demonstrate responsibility as the DM lead on studies/projects;Deep understanding of the drug development process;Strong organizational skills and able to collaborate with minimal supervisionSignificant 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.Preferred Qualifications:Basic SAS Programming knowledge, or other database experience.Country: United StatesState: New JerseyLocation: WhippanyReference Code: 65241Functional Area:Computational Science, Data Science & StatisticsEntry Level : Professional
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