Consultant advising clients on designing and operating modern IT and Digital models. Leading teams in AI adoption, cloud transformation, and complex service ecosystems.
About the role
- Associate II handling TMF operations ensuring compliance in clinical trials. Collaborating with global teams to maintain quality and adherence to regulatory standards.
Responsibilities
- Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles
- Process, review, and resolve rejected Trial Master File (TMF) documents
- Prepare periodic TMF Quality Control checklists for review by Project Team
- Perform periodic TMF Quality Control to ensure adherence to regulatory and industry best practices
- Work with a variety of Electronic Document Management and electronic TMF Systems
Requirements
- University Degree preferred (Life Science desirable)
- Up to 1-2 year of relevant experience
- Knowledge of working within a highly regulated industry (desirable)
- Possess data collection, indexing and editing skills
- Excellent written and verbal communication skills
- Strong interpersonal skills in fast-paced, deadline oriented environment
- Strong planning and organizational skills
- Proficiency in Microsoft Word and Excel
- General understanding of clinical research principles and processes
- Develop proficiency in use of an electronic document repository or eTMF
Benefits
- Collaborative and innovative workplace
- Diverse and inclusive environment
- Opportunities for professional development
- Commitment to enabling professionals from all backgrounds to succeed
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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