Remote Job Fortrea Hiring TMF Lead II. Apply for senior eTMF jobs with leadership opportunities in global clinical research.
Company Overview
Fortrea is a globally recognized clinical research organization (CRO) known for delivering advanced clinical development, data management, and regulatory solutions to pharmaceutical and biotechnology companies. With operations across multiple continents, Fortrea supports sponsors through all phases of clinical trials, from early-stage development to post-marketing studies.
The organization is widely respected for its expertise in Trial Master File (TMF) management, clinical data quality, and regulatory compliance. Fortrea provides professionals with opportunities to work on global studies while building long-term careers in specialized clinical research domains. Remote Job Fortrea Hiring TMF Lead II
Job Location & Employment Type
- Primary Location: Bangalore, India
- Work Mode: Remote (India-based)
- Employment Type: Full-time
- Travel: Minimal (occasionally required for meetings or audits)
Open Position
TMF Lead II – Electronic Trial Master File (eTMF)
Department: Clinical Operations / TMF Management
This is a senior-level role responsible for end-to-end Trial Master File oversight, including setup, maintenance, compliance monitoring, and audit readiness across complex clinical studies. Remote Job Fortrea Hiring TMF Lead II
Key Roles & Responsibilities
The TMF Lead II will oversee the lifecycle management of Trial Master Files while ensuring compliance with global regulatory standards and sponsor expectations. Remote Job Fortrea Hiring TMF Lead II
TMF Strategy & Oversight
- Manage study TMF from initial setup through closure and transfer.
- Act as the primary TMF delivery lead for assigned studies.
- Conduct TMF kickoff meetings with sponsors and internal teams.
- Define TMF expectations aligned with ICH and regulatory standards.
- Develop and maintain the TMF Plan and TMF Index in collaboration with project stakeholders.
eTMF Operations
- Oversee planning, setup, and maintenance of electronic TMFs across Phase I–IV studies.
- Ensure appropriate system access for internal and external stakeholders.
- Maintain user permissions in coordination with access management teams.
- Ensure completion of required eTMF system training for project teams.
Compliance & Quality Management
- Ensure adherence to sponsor and Fortrea SOPs for TMF handling.
- Identify and document process deviations and compliance risks.
- Escalate TMF quality issues and track CAPA implementation.
- Maintain TMF readiness for regulatory inspections and audits.
- Oversee quality control workflows and milestone-based reviews.
TMF Completeness & Review Workflows
- Monitor Expected Document Lists (EDLs) and ensure accurate indexing.
- Drive real-time TMF completeness across study milestones.
- Initiate TMF review workflows within defined timelines.
- Identify missing or incomplete documents and coordinate remediation.
- Conduct regular meetings with study teams to review TMF health.
Audit & Inspection Readiness
- Prepare TMFs for sponsor and regulatory audits.
- Participate in audit discussions and remediation planning.
- Respond to findings in collaboration with management teams.
- Ensure TMF artifacts meet global regulatory standards.
Reporting & Governance
- Track TMF metrics and provide KPI reports at study and portfolio levels.
- Identify trends and recommend corrective actions.
- Support governance meetings and project reviews.
- Handle sponsor-specific reporting requests where applicable.
Collaboration & Leadership
- Provide TMF training to study teams as required.
- Mentor junior TMF professionals and support capability building.
- Act as a point of contact for TMF system-related technical issues.
- Collaborate with TMF operational services and cross-functional teams.
- Support business development and client engagement activities.
Additional Responsibilities
- Support TMF remediation initiatives and migration projects.
- Develop process documentation such as work instructions and job aids.
- Maintain awareness of evolving regulatory requirements.
- Contribute to continuous improvement initiatives in TMF operations.
Remote Job Fortrea Hiring TMF Lead II
Eligibility Criteria
Education
- Bachelor’s degree in:
- Life Sciences
- Pharmacy
- Biotechnology
- Business (with clinical research experience)
Equivalent industry experience may be considered in place of formal education.
Preferred: Master’s degree in Life Sciences or Business-related disciplines.
Experience
- Minimum 8 years of experience in:
- Clinical research environments
- Trial Master File management
- eTMF systems and regulatory documentation
Experience managing complex global studies is strongly preferred.
Skills Required
- Strong expertise in eTMF lifecycle management.
- Deep understanding of GCP and ICH guidelines.
- Knowledge of regulatory documentation standards.
- Experience with electronic clinical systems and document platforms.
- Strong leadership and stakeholder management skills.
- Excellent communication and presentation abilities.
- High attention to detail and compliance orientation.
- Ability to manage multiple studies simultaneously.
- Proficiency in Microsoft Office and document management tools.
- Experience with audit readiness and CAPA processes.
Salary & Benefits
- Salary: As per company norms (senior-level compensation)
Potential benefits may include: - Remote working flexibility
- Global project exposure
- Leadership and mentoring opportunities
- Career advancement in TMF and clinical operations
- Inclusive and collaborative work culture
Benefits may vary based on role location and company policies. Remote Job Fortrea Hiring TMF Lead II
Selection Process
The recruitment process typically includes:
- Application shortlisting
- HR screening
- Technical interview (TMF expertise)
- Leadership or client-facing round
Senior roles may involve additional evaluation based on experience.
How to Apply
Interested candidates should apply through the official Fortrea careers portal before the deadline.
While applying, ensure your CV highlights: Remote Job Fortrea Hiring TMF Lead II
- eTMF leadership experience
- Audit readiness exposure
- Global clinical trial involvement
- TMF governance or compliance expertise
Important Dates
- Application Deadline: March 3, 2026
Due to the short deadline, early applications are strongly recommended.
Why Apply for This Pharma Job?
This is an excellent opportunity for experienced TMF professionals aiming to advance into leadership roles within global clinical trials. Key advantages include:
- Remote work flexibility across India
- Senior-level role with strategic responsibilities
- Exposure to global regulatory audits and inspections
- Opportunity to lead complex multinational studies
- Strong career growth in TMF and clinical operations leadership
If you are looking to move into a high-impact TMF leadership role, this position offers both visibility and long-term growth. Remote Job Fortrea Hiring TMF Lead II
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform providing verified pharma and clinical research job updates. We are not affiliated with Fortrea or any hiring organization. Applicants should apply only via official company channels and verify all details independently. Remote Job Fortrea Hiring TMF Lead II
Final Call-to-Action
If you have extensive TMF experience and want a senior remote opportunity in global clinical research, this Fortrea TMF Lead II role is worth exploring. Apply now and step into a leadership position in trial master file management. Remote Job Fortrea Hiring TMF Lead II
