Senior Clinical Data Manager

YOUR TASKS AND RESPONSIBILITIES

DM Expertise - 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.

PDM/EPDM tasks - Governs use of key data management elements across studies in assigned projects: assumes ownership of development and maintenance of Medical Standards relevant to the area of responsibility; contributes to the definition of data structure standards; review applied results of the Important Medical Event (IME) List and, medical coding conventions.

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. Incorporates and maintains Medical Standards in clinical studies and projects for all elements of the medical standards package.

Provides governance and oversight for outsourcing activities by providing input on budgetary items (e.g. RFP, vendor costing, synergies,

WHO YOU ARE

The Senior Clinical Data Manager leads and/or supports 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 Senior Clinical Data Manager may assume the business role of a Study Data Manager in one or more clinical studies. In this capacity, s/he serves as the primary contact for Data Management on the Core Study Team.

As an SDM, the Senior Clinical Data Manager leads the DM 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 Senior 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 Senior Clinical Data Manager may also assume the role of a Project Data Manager (PDM) or Early Project Data Manager (EPDM).

In this role, the PDM/EPDM 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.

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