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Job Description
Objectives:
- Manage the Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF).
- Oversee the review, approval, and accuracy of eTMF documents.
- Generate reports to measure completeness, accuracy, and timeliness of the eTMF.
Accountabilities:
- Develop study-specific eTMF plans for clinical studies.
- Perform quality control of documents in the eTMF.
- Ensure documentation complies with eTMF specifications, ICH-GCP guidelines, regulatory requirements, and SOPs.
- Address eTMF-related questions and provide system user support.
- Remediate documents that fail quality control and provide best practice recommendations.
- Maintain Essential Document Lists (EDLs) continuously.
- Monitor study-specific eTMF trends and communicate with Clinical Operations or other functional teams.
- Assist with inspection and audit-related activities.
- Stay updated on the TMF Reference Model, industry best practices, and regulatory requirements.
- Support Clinical Operations Lead/Manager in overseeing CROs.
- Collaborate with study teams to configure CTMS according to study requirements.
- Manage end-user and group permissions settings.
- Lead meetings to address trends, issues, and establish industry standards.
- Continuously assess and improve CTMS functionality; track issues for future enhancements or training needs.
Education, Behavioral Competencies, and Skills:
- Minimum Bachelor’s degree in science/healthcare field.
- 3+ years of clinical research and TMF experience at a biotech, pharmaceutical company, or CRO.
- Experience with eTMF system software, preferably Veeva Vault CTMS & eTMF.
- Good knowledge of GCP and local clinical trial regulations.
- Strong organizational and problem-solving skills.
- Superior communication, strategic, interpersonal, and negotiating skills.
- Proven stable performance over the past 2-3 years.
Travel Requirements:
- Domestic travel: 20-30%, including some weekends.
- International travel: 10-20%.
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full-time
Locations: Gurgaon, Haryana, India