Job Description:

LOCATION:

JOB OVERVIEW

The TMF Lead is responsible for day-to-day TMF leadership for assigned clinical studies. The role coordinates study TMF activities, provides status and risk information to stakeholders, and directs the work of supporting TMF Specialists and Associates. The TMF Lead creates and maintains the TMF Plan, leads or creates the TMF build, and coordinates periodic TMF quality control and remediation with oversight from TMF management.

JOB DUTIES AND RESPONSIBILITIES

- Coordinates TMF activities across the lifecycle of assigned studies and serves as the routine TMF contact for the study team.
- Creates, maintains, and implements the study-specific TMF Plan and associated records with review and approval from the Project Manager and Sponsor.
- Leads the initial TMF build for assigned studies, including structure, expected document packages and ad hoc placeholder creation in accordance with approved standards.
- Maintains TMF expectations as study scope, milestones, countries, sites, vendors, or responsibilities change.
- Plans and coordinates periodic TMF QC in accordance with the TMF Plan and procedures, including assignment, completion tracking, documentation, and follow-up.
- Reviews periodic QC findings, coordinates remediation, verifies completion, identifies repeat issues, and escalates significant trends or unresolved actions.
- Monitors TMF completeness, quality, and timeliness and provides regular status reports to study and functional stakeholders.
- Coordinates document collection, review, indexing, filing, reconciliation, and issue resolution across internal and external contributors.
- Identifies and investigates missing, incomplete, inconsistent, late, or misfiled documents and assigns or escalates corrective actions.
- Provides task direction, priorities,



and technical guidance to TMF Specialists and Associates supporting assigned studies.
- Participates in study meetings and communicates TMF requirements, status, risks, actions, and upcoming milestones.
- Interacts directly with sponsors to provide TMF status updates, discuss risks and actions, confirm expectations, and support study decisions within delegated authority.
- Supports audit and regulatory inspection readiness, document retrieval, response preparation, and remediation.
- Coordinates final TMF review, reconciliation, closeout, transfer, archival, and sponsor return activities.
- Provides TMF training and eTMF system support to TMF Specialists and Associates, study team members, sponsors, and other users and escalates system issues when required.
- Escalates material risks, recurring quality issues, resource concerns, and decisions outside delegated authority.
- Performs other related duties as assigned by departmental management.

SUPERVISORY RESPONSIBILITIES

No routine direct supervisory responsibility. Provides study-level task direction and technical guidance to TMF Specialists and Associates assigned to the study.

JOB REQUIREMENTS

EDUCATION

- College or university degree. A healthcare, life science, information management, or related degree is a plus.
- An equivalent combination of education and relevant work experience may be considered.

EXPERIENCE





- Typically minimum of six years of experience in TMF, records management, clinical operations, or a related regulated function.
- Experience coordinating TMF activities and working with cross-functional study teams.
- Experience creating or maintaining TMF Plans, supporting or leading TMF builds, and coordinating periodic TMF QC is preferred.

SKILLS/COMPETENCIES

- Strong written and verbal communication skills in English
- Strong interpersonal skills and the ability to collaborate with global internal and external study teams
- Strong computer skills, including Microsoft Office and electronic Trial Master File systems
- Knowledge of the clinical trial lifecycle, essential documents, and applicable TMF requirements
- Knowledge of ICH Positive Clinical Practice and applicable regulatory requirements
- Exceptional attention to detail and a consistent focus on document quality
- Strong organizational skills with the ability to manage competing priorities and timelines
- Ability to work effectively in a dynamic and changing environment
- Demonstrates honesty, trust, fairness, cooperation, self-control, and flexibility
- Strong working knowledge of TMF structure, essential documents, metadata, and records lifecycle activities
- Strong coordination, facilitation, problem-solving, and escalation skills
- Ability to interpret reports and QC findings and coordinate appropriate remediation
- Ability to work independently within approved plans, procedures, and delegated authority

CAPABILITIES

- Able to work flexible hours to accommodate study team and sponsor requirements
- Able to travel based on study and business need
- Able to perform office-based or remote work as assigned
- Minor lifting of less than 30 pounds may be required

📌 TMF Lead (India)
🏢 Caidya
📍 India