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eTMF Manager

Cambridge, MA 02142

Posted: 11/27/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 591790 Is job remote?: No Country: United States

Job Description

Target PR Range: 50-80/hr
*Depending on experience

The Clinical Trial Systems Operations team within Clinical Trial Excellence and Support is looking for an agile, self-motivated, and experienced individual to be responsible for working across clinical trials to implement and execute on eTMF strategy, governance, and processes, and review/conduct quality checks of eTMFs and related documentation. This role will also manage filing and maintenance activities for clinical trials during the study start-up, maintenance, and close-out periods. The successful candidate will be detail-oriented with a flexible and solution-oriented outlook with the ability to support team members within and with our CRO partners.

Here’s What You’ll Do:

Maintains effective communication with clinical study teams, CRO staff, and eTMF vendor personnel throughout study start-up, maintenance, and close-out

Supports TMF document filing into eTMF system

Authors initial TMF plans

Maintains a naming and filing guide specific to TMF documents

Performs routine quality checks of documents uploaded into the eTMF

Responds to inquiries regarding TMF management and contents

Attends departmental and study-specific meetings and discussions, as required

Runs routine eTMF reports and monitors TMFs for completeness and trends

Supports system updates by participating in user acceptance testing and system enhancement discussions

Completes other TMF document-related tasks as required by the study teams or the Clinical Trial Excellence department

Here’s What You’ll Bring to the Table:

BA/BS required; Advanced degree preferred.

5+ years of experience in a clinical research environment within the pharmaceutical and biotech industry.

eTMF document management experience.

Clear and timely communication skills.

Proficiency with clinical research documents, their contents, and purpose, and working knowledge of GCP and regulatory requirements

Strong organizational/prioritization skills for the management of workload and attention to detail

Demonstrated proficiency with eTMF applications

*CO/NYC candidates might not be considered
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