200 Tech Square Cambridge, MA 02142 US
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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