About The Client: Leaders in specialist recruitment and workforce solutions, offering advisory services such as learning and skill development, career transitions and employer brand positioning. As the Leadership Partner to our customers, we invest in lifelong partnerships that empower people and businesses to succeed. We help you achieve your career goals and deliver your business needs by combining meaningful innovation with our global scale and insights. Last year we helped over 280,000 people find their next career. Join the millions of people around the world that our specialist recruitment consultants provide with up-to-date information on career options, interesting insights and specific industry trends. We help our customers define and implement strategies to create inclusive and equitable workplaces. Through harnessing and analysing data, we support business decision making and advise on how to access Talent Networks. We also assist in identifying attractive employer propositions by truly understanding a company's identity, and support clients with all aspects of their Early Careers proposition, from strategic planning through to operational execution. Hays is the market leader in the UK and Asia Pacific and one of the market leaders in Continental Europe and Latin America. The c.12,800 people we employ around the world partner with clients and candidates to power the world of work. Every day our expert consultants help thousands of candidates find their next role, and they also help clients reshape workforces and deal with talent shortages. In the year to 30 June 2021, we placed 77,000 people in permanent jobs and 244,000 people into temporary roles.
About The Job:
The TMF co-ordinator provides day-to-day support for the preparation and management of TMF documents before uploading and indexing in the eTMF system.
This role ensures the accuracy and completeness of clinical documentation, contributing to inspection-readiness and compliance with global regulatory requirements.
The TMF co-ordinator works collaboratively with clinical project teams and supports smooth TMF operations.
In addition, the TMF co-ordinator is responsible for the management and maintenance of the AstraZeneca study-specific TMF index, including EDL updates and records management in the eTMF platform.
The TMF co-ordinator provides day-to-day operational support to sponsor clinical trial teams, ensuring study-specific TMF index management and inspection readiness.
The role includes performing periodic TMF checks, identifying gaps, and collaborating with the TMF Manager for oversight and resolution.
Essential Job Functions:
Provide Pre-QC (Quality Control) of documents prior to upload and indexing in the eTMF system
Support maintenance and management of TMF records for assigned clinical trials
Ensure timely and accurate uploading, naming, and indexing of clinical documentation
Collaborate with study teams to resolve document queries and discrepancies
Maintain compliance with the DIA Reference Model for TMFs and ICH GCP guidelines
Uphold established standards for documentation accuracy, completeness, and traceability
Assist with TMF filing and document retrieval as required
Support TMF readiness for regulatory audits and inspections
Manage study-specific TMF index and document records in the eTMF system (e.g., Veeva Vault)
Maintain and update Electronic Document List (EDL) for assigned studies
Provide operational support to clinical trial teams for TMF index management and inspection preparedness
Conduct periodic TMF checks; share identified queries and gaps with the TMF Manager
Ensure TMF records are compliant with DIA Reference Model, ICH GCP, and regulatory requirements
Support timely and accurate filing of clinical research documents
Collaborate cross-functionally to ensure consistent documentation processes
Assist in TMF readiness for audits and inspections
Qualifications:
1-5 yrs experience
Bachelor's degree in life sciences, healthcare, pharmacy, or related field
Minimum of 1 year of relevant experience in clinical operations and/or clinical document management (eTMF preferred)
Working knowledge of clinical research documents
Knowledge of ICH GCP and regulatory guidance
Skilled in verbal and written communication
Computer literate; proficiency in Microsoft Office suite (Word, Excel etc)
Desirable
Experience with Veeva Vault or similar eTMF platforms
Knowledge of the DIA Reference Model for TMFs
Experience in a fast-paced, cross-functional environment
Familiarity with eCTD binders, CSR
How to Apply: Interested candidates are encouraged to respond/submit their updated resumes, and for additional job opportunities, please visit Jobs In India - VARITE.
Unlock Rewards: Refer Candidates and Earn. If you're not available or interested in this opportunity, please pass this along to anyone in your network who might be a good fit and interested in our open positions. VARITE offers a Candidate Referral program, where you'll receive a one-time referral bonus based on the following scale if the referred candidate completes a three-month assignment with VARITE.
Experience Level Bonus Referral:0-2 years INR 5,000 2-6 years INR 7,500 6+ years INR 10,000 About VARITE: VARITE is a global staffing and IT consulting company providing technical consulting and team augmentation services to Fortune 500 Companies in USA, UK, CANADA and INDIA. VARITE is currently a primary and direct vendor to the leading corporations in the verticals of Networking, Cloud Infrastructure, Hardware and Software, Digital Marketing and Media Solutions, Clinical Diagnostics, Utilities, Gaming and Entertainment, and Financial Services.
Equal Opportunity Employer: VARITE is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, veteran status, or disability status.
