ICON plc: TMF Specialist I & II – Chennai, India
Shape the Future of Clinical Research. Join ICON plc!
Summary:
ICON plc, a leading global provider of clinical research services, is seeking highly motivated and detail-oriented individuals to join our team in Chennai, India, as TMF Specialist I and TMF Specialist II. This is a fantastic opportunity for experienced clinical research professionals with a strong background in eTMF, Veeva Vault, and clinical trial documentation to contribute to impactful clinical trials and advance their careers within a dynamic and supportive environment. If you are passionate about ensuring the integrity and compliance of clinical trial data, we encourage you to apply!
Job Overview:
As a TMF Specialist at ICON plc, you will play a crucial role in the management and maintenance of Trial Master Files (TMFs) for assigned clinical studies. You will be responsible for ensuring TMF completeness, accuracy, and compliance with all relevant regulatory guidelines and sponsor requirements. Your expertise in eTMF systems, particularly Veeva Vault, will be essential in maintaining up-to-date and audit-ready documentation throughout the clinical trial lifecycle.
Key Responsibilities:
- TMF Management: Manage, maintain, and oversee the Trial Master File (TMF) for assigned clinical studies, adhering to established timelines and quality standards.
- Compliance & Accuracy: Ensure TMF completeness, accuracy, and compliance with ICH-GCP guidelines, sponsor standards, and internal Standard Operating Procedures (SOPs).
- Quality Control: Perform ongoing TMF quality checks and reconciliation activities to identify and resolve any discrepancies or missing documentation.
- Veeva Vault Administration: Maintain and update the Veeva Vault eTMF system according to project timelines, ensuring accurate document filing and organization.
- Collaboration: Collaborate effectively with clinical operations teams, project managers, and Quality Assurance (QA) teams to ensure seamless TMF management across all study phases.
- Audit & Inspection Readiness: Support audit and inspection readiness activities across studies by proactively identifying and addressing potential TMF-related issues.
- Documentation & Filing: Ensure timely and accurate document filing and adherence to TMF standards, maintaining a high level of organization and efficiency.
Required Qualifications:
- Experience: A minimum of 1 year of experience in eTMF operations is required for the TMF Specialist I position. The TMF Specialist II position will require additional years of experience in eTMF operations.
- eTMF Expertise: Hands-on expertise with Veeva Vault eTMF is essential, including experience with document upload, indexing, and retrieval.
- Clinical Trial Knowledge: A strong understanding of clinical trial documentation requirements and best practices.
- Regulatory Compliance: A solid understanding of ICH-GCP guidelines and relevant regulatory requirements related to TMF management.
- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
- Skills: Excellent organizational skills, attention to detail, and the ability to prioritize tasks effectively.
- Communication: Strong written and verbal communication skills.
- Problem Solving: Ability to identify and resolve TMF-related issues independently and proactively.
- Teamwork: Ability to work collaboratively in a team environment.
Benefits of Working at ICON plc:
- Global Leader: Opportunity to work with one of the world’s largest and most respected Clinical Research Organizations (CROs).
- Global Exposure: Gain exposure to global clinical research operations and collaborate with international teams.
- Competitive Compensation: Competitive salary and benefits package, with opportunities for performance-based growth.
- Professional Development: Comprehensive training and development programs to support your professional advancement.
- Supportive Culture: Collaborative and supportive work environment where your contributions are valued.
- Impactful Work: Make a real difference in the lives of patients by contributing to the development of new and innovative therapies.
How to Apply:
If you meet the qualifications outlined above and are eager to join a dynamic and growing team, we encourage you to apply! Please submit your updated resume to:
We look forward to reviewing your application and discussing this exciting opportunity with you.