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Associate II – TMF Operations
Worldwide Clinical TrialsTMF Operations Associate processing and quality-checking clinical-trial documents for Worldwide Clinical Trials, a global contract research organization. Supporting regulatory compliance across complex studies and Sponsor portfolios.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates proficiency in Trial Master File (TMF) management, including quality control and adherence to regulatory standards. Possesses strong data collection, indexing, and editing skills, along with effective communication and organizational abilities.
Highest-signal resume keywords
TMF ApproverTMF QC ReviewerElectronic Document ManagementMicrosoft WordMicrosoft Excel
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data CollectionIndexingEditingDocument Naming ConventionsTMF Quality ControlElectronic TMF SystemsClinical Research PrinciplesRegulatory ComplianceAttention to DetailOrganizational Skills
Soft Skills
Excellent CommunicationInterpersonal SkillsPlanning SkillsAdaptabilityTime Management
Tools & Technologies
Electronic Document RepositoryETMF
Industry Keywords
CROPharmaICH GCPBest PracticesTrial Master File
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Fulfil the “TMF Approver” and/or “TMF QC Reviewer” roles according to relevant SOPs and working practices
- Process, review, and resolve rejected Trial Master File documents for complex studies or Sponsor portfolios in electronic and hard copy formats
- Prepare periodic TMF Quality Control checklists for Project Team review
- Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices
- Use Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents
- Collaborate regularly with members of the Worldwide Project Team
Requirements
What you’ll need- Data collection, indexing, and editing skills
- Ability to adhere to standardized document naming conventions
- Excellent written and verbal communication skills
- Strong interpersonal skills in a fast-paced, deadline-oriented, rapidly changing environment
- Ability to handle multiple, highly detailed tasks with exceptional accuracy
- Strong planning and organizational skills
- Proficiency in Microsoft Word and Excel
- Ability to develop proficiency in an electronic document repository or eTMF
- General understanding of clinical research principles and processes
- University Degree preferred; Life Science desirable
- Up to 1–2 years of relevant TMF experience within the CRO/Pharma industry
Benefits
Comp & perks- Supportive and cohesive teams
- Diverse and inclusive work environment
- Equal employment opportunities
- Exceptional employee experiences
- Opportunity to collaborate with global project teams