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Associate II, TMF Operations
Worldwide Clinical TrialsTMF Operations role focused on reviewing and processing essential documents for clinical trials at Worldwide Clinical Trials. Collaborating with global project teams to ensure regulatory compliance.
About the role
Key responsibilities & impact- Fulfil the TMF Approver and/or TMF QC Reviewer roles as defined by relevant SOPs
- Process, review, and resolve rejected TMF documents for complex studies
- Prepare periodic TMF Quality Control checklists for Project Team review
- Perform TMF Quality Control to ensure adherence to regulatory and industry best practices
- Work with Electronic Document Management and eTMF Systems to review Essential Documents
Requirements
What you’ll need- Minimum 6 months of administrative experience, preferably in the CRO or Pharma industry
- Knowledge of working within a highly regulated industry (desirable)
- Strong long-term interest in administrative-focused work, with attention to detail
- Strong skills in data collection, indexing, and editing
- Excellent written and verbal communication skills
- Strong interpersonal skills in a fast-paced, deadline-oriented environment
- Proficiency in Microsoft Word and Excel
Benefits
Comp & perks- Culture of collaboration and innovation
- Diverse and inclusive environment
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data collectionindexingediting
Soft Skills
attention to detailwritten communicationverbal communicationinterpersonal skills