Associate II, TMF Operations
New
Europe/Latam- RemoteFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- Up to 1-2 years of relevant TMF experience within the CRO/Pharma industry
- Required Skills
- Microsoft Excel
Requirements
- 1-2 years of relevant TMF experience within the CRO/Pharma industry.
- University degree (Life Science desirable).
- Data collection, indexing, and editing skills.
- Ability to adhere to standardized document naming conventions.
- Proficiency in Microsoft Word and Excel.
- Understanding of clinical research principles and processes.
- Strong interpersonal, planning, and organizational skills.
- Ability to handle multiple highly detailed tasks with accuracy.
- Excellent written and verbal communication skills.
Responsibilities
- Fulfil the TMF Approver and/or TMF QC Reviewer roles as defined by SOPs.
- Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies.
- Prepare periodic TMF Quality Control checklists for project team review.
- Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, and industry best practices.
- Work with electronic document management and eTMF systems to review, classify, and process essential documents.
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