eTMF Manager

eTMF Manager
  • $50 - $80 per Hour
    HOUR
  • Temporary
  • CAMBRIDGE MA, US CAMBRIDGE MIDDLESEX US 02139
Job Ref: JO000127308
Sector: Science
Sub-sector: Food & FMCG
Date Added: 06 January 2022

eTMF Manager Clinical Development

6 month Contract with possible renewal.

Description:

The Role:

The Clinical Operations team at Moderna is looking for an agile, self-motivated, and experienced individual to be responsible for working across clinical study teams to design and implement eTMF strategy, governance, and processes, and review/conduct quality checks of eTMFs and TMF documentation across the portfolio. 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 Moderna 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 Moderna eTMF system
  • 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
  • Performs general administrative tasks
  • Completes other TMF document-related tasks as required by the study teams or the Clinical Operations department
  • Here’s What You’ll Bring to the Table:
  • Life sciences degree or certification in a related allied health profession from an accredited institution (e.g., nursing, medical or laboratory technology) or equivalent
  • 5+ years experience in clinical trials (e.g., study coordinator, regulatory operations) and 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 with attention to detail a must
  • Demonstrated proficiency with eTMF applications (Veeva Vault Clinical eTMF experience a plus), word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)

#LI-KR1

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRGTalent
06/02/2022 12:00:00
USD 50.00 80.00 Hour
Contact Consultant:
Katherina Ramirez

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