Clinical Data Manager

Vor 5 Tagen

Basel, Schweiz Coopers Group AG Vollzeit

**Clinical Data Manager**

The Role:
The Clinical Data Manager role is responsible for all aspects of the clinical trial data

management process from study start up through database lock and support of clinical

study report (CSR) activities for assigned studies. This role may be expected to lead multiple

clinical studies.

**Responsibilities**:

- Serve as lead CDM on assigned clinical trials by attending internal and external clinical trial

project team meetings.
- Responsible for the study-specific data management tasks from protocol review to

database lock to ensure data are collected, reviewed, and delivered with high quality, ontime,

and within scope.
- Responsible for the accurate development of CRFs and edit specification per protocol and

the completeness of user acceptance testing of CRFs and associated edit specifications for

assigned clinical trials.
- Provide ad-hoc report development, and support database lock and archiving activities.
- Review and contribute as a member of the CRF development team to develop the data

collection modules on assigned studies where protocol requirements are outside of

standard CRF library versions.
- Ensure that medical coding is completed in a timely fashion, completed for all data cuts,

and reviewed and approved by medical monitors.
- Participate in the development of standard operating procedures (SOPs).

**Profile**:

- Experience in clinical data management for 5+years.
- Experience in vendor management of outsourced studies
- Demonstrate strong medical terminology skills.
- Experience defining, entering, processing, reviewing, and validating clinical data; and

understanding and following clinical trial protocols and data collection documents.
- Medidata Rave experience required.
- Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.
- Possess effective written and verbal communication skills, interact professionally with

personnel at all levels within and external to the company, and be dependable and a team

player.

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