Senior Clinical Data Manager

**Senior Clinical Data Manager**

**Position Purpose**:
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.

**Scope**: Global

**Major tasks and responsabilities**:
**_DM Expertise_**

**_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.

Incorporates and maintains Medical Standards in clinical studies and projects for all elements of the medical standards package.
- Advises on resource planning/allocation based on forecasted clinical activities per the Clinical Development Plan (CDP) and actual study/project metrics.
- Ensures smooth phase-transitioning of projects between research and development phases within P&O.
- 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.
- 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.

**_SDM tasks_**
- 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)
- Incorporates and maintains Medical Standards in clinical studies for all elements of the medical standards package.
- Documents 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 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.
- Specifies and develops study specific eCRFs, data consistency checks based on Medical Standards, the Clinical Study Protocol and input from the study team.
- Prepares, tracks and implements 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.

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
- As applicable, plans and tracks data contributions of specialized functions typically used for early clinical development activities like