As a TMF Specialist II, you will be part of the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. This role is based in Chennai and offers an opportunity to work on cutting-edge clinical trials, ensuring high standards in Trial Master File (TMF) management and compliance.
Responsibilities
TMF Management and Compliance
- Maintain effective communication with clinical trial teams and CRO staff throughout all trial phases—start-up, maintenance, close-out, and archive.
- Manage eTMF Health by overseeing Quality Issue (QI) lists, ensuring documents that fail TMF quality checks are addressed and resolved.
- Partner with the Clinical Trial Team (CTT) and CRO team to manage Expected Document Lists (EDLs) and ensure compliance throughout the trial lifecycle.
Quality Control and Review
- Conduct ad-hoc quality checks and reviews of document content uploaded into the eTMF system.
- Provide scheduled and ad-hoc analyses and metrics on TMF Health for assigned trials.
- Support inspection and audit preparation, along with remediation activities.
Administrative Support
- Ensure proper filing and naming of TMF documents in the eTMF system.
- Respond to inquiries regarding TMF management and contents.
- Perform general administrative tasks related to TMF document management.
Qualifications
- A Bachelor’s degree (B.A./B.S.) in science, healthcare, or a related field is preferred.
- A minimum of 2+ years of work experience in a relevant clinical research setting.
- At least 1+ year of experience in eTMF document management is an advantage.
- Strong organizational and prioritization skills, with attention to detail.
- Up-to-date knowledge of the TMF Reference Model, industry best practices, and regulatory requirements is a plus.
Skills and Competencies
- Excellent communication skills to collaborate effectively with trial teams and CRO staff.
- Strong understanding of clinical trial processes and TMF health metrics.
- Problem-solving abilities to address quality issues and non-compliance effectively.
- Knowledge of eTMF systems and document management best practices.
