Clinical Data Manager

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JOB DESCRIPTION
The Clinical Data Manager (CDM) is responsible for clinical data management operations and activities such data review (Query management, data listings review etc.) including external lab vendor and SAE reconciliations. CDM is also responsible for EDC testing and data cleaning.

The CDM should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; understand the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.

ESSENTIAL FUNCTIONS

• Support Internal Clinical Data Management Initiatives
• Complete assigned Data Management Operations/Activities
• Review CRF/eCRF data for completeness, accuracy, and consistency via system edits and
manual data checks (data review listings)
• Contribute to Project Success by conducting duties per LDM/Study lead request.
• Freeze and/or lock eCRFs (as appropriate) within the Electronic Data Capture System (Medidata rave, Veeva EDC etc.)
• Perform external vendor reconciliations.
• Perform SAE reconciliation.
• Code data per selected coding dictionaries if applicable.
• Participate in User Acceptance Testing (UAT) under supervision of the Study Lead.
• Assist with data transfers, loading and integration.
• Complete all required documentation per EDETEK and project requirements
• Manage allocated tasks with minimal oversight, ensuring deliverables meet quality standards and customer expectations.

QUALIFICATIONS FOR ESSENTIAL FUNCTIONS

1. Ability to communicate effectively in the English language in person, by phone and in writing.
2. Strong attention to detail and accuracy is a must
3. Excellent organizational skills
4. Ability to work collaboratively, effectively, and productively in diverse organization structures.
5. Ability to work in a team-oriented, collaborative environment.
6. Ability to work positively within a continually changing environment.
7. Ability to effectively prioritize and execute tasks in a high-pressure environment.


EDUCATION AND EXPERIENCE REQUIRED

1. A bachelor's degree in life sciences is required.
2. A minimum of 2 years of core clinical data management experience is required.
3. Prior trial responsibility for the entire data management life-cycle is desirable.
4. Prior experience in external data vendor reconciliation and SAE reconciliation is required.
5. Prior experience of EDC UAT is preferred.


WORK REQUIREMENTS

1. Corporate office environment or remote.
2. Cross-functional interactions

TRAINING

• Complete Training Requirements per current Training Requirements List.
• Supervisor may assign additional skills training, one-on-one, see-one / do one, or other Training as necessary to achieve qualifications and improve job performance.
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