Clinical Trial Lead

Role & Responsibilities
• Provide Pre-QC 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 the 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 and 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.

Qualification
• Bachelor’s degree in life sciences, healthcare, pharmacy, or related field.

Experience
• 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.

Vacancies
• 30 Vacancies

Skills
• Skilled in verbal and written communication.
• Proficient in Microsoft Office suite (Word, Excel, etc.).
• 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 and CSR.

About The Company
VARITE is a global staffing and IT consulting company providing technical consulting and team augmentation services to Fortune 500 companies in the USA, UK, Canada, and India. The company works across multiple verticals such as Networking, Cloud Infrastructure, Clinical Diagnostics, Gaming, and Financial Services. VARITE is committed to creating an inclusive work environment and is an equal opportunity employer.