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**Clinical Data Manager**

**Position Purpose**:
The **Clinical Data Manager (CDM)** leads and/or supports the execution of data management activities necessary for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community. The CDM may assume the business role of a Study Data Manager in studies with standard complexity. 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 potentially includes the co-accountability with the Statistics Lead to create, maintain and manage the Project Plan.

The CDM may support SDMs for complex trials to ensure completion of tasks in a timely manner at high quality.

**Scope**:Global

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

**_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 studie 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, contributes to the database structure.
- Contributes or drives preparation, tracking and implementation of 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 Pharmacokinetics, Biomarker, Bioinformatics, Pharmacometrics, as well as strategic operational partners.
- As applicable, establishes 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. This includes but is not limited to the following: 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.

**_Operational Data Management_**
- Identifies and issue queries, incorporates query replies and tracks query status.

**_Implementing Strategy_**
- Contributes to projects and initiatives aimed at improving and optimizing the delivery of DMAR and CDM, OSBU DM.

**_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.

**Value added**:
Clinical trials data management is a highly regulated and compliance driven environment. The timely delivery of high quality data is directly linked to the extent that the company can make decisions on continuation of development programs, or that the company can claim, and prove its portfolio assets are safe, effective and marketable. The **Clinical Data Manager** is supports or is responsible for the consistency in support, planning and delivery of data m