What are the responsibilities and job description for the TMF Lead position at BioSpace?
Position Summary
The TMF Lead is an independently resourceful subject matter expert (SME) responsible for the quality, completeness, and inspection readiness of Trial Master Files (TMFs) across assigned clinical studies, from study startup through study closeout and archive, within the Veeva TMF (Vault) system. Operating in a small biotech environment with competing priorities, the TMF Lead works with minimal oversight, serving as the primary go-to resource for all TMF-related questions and driving TMF operational excellence in close collaboration with Clinical Operations, Data Management, Regulatory Affairs, Biostatistics, Pharmacovigilance, Quality Assurance, and external CROs/vendors, in adherence to company SOPs, ICH-GCP, and applicable regulatory requirements.
Responsibilities
Lead and own TMF activities across assigned clinical studies from study startup through closeout and archival, ensuring TMF completeness, quality, and continuous inspection readiness at every phase of the trial, within the Veeva TMF (Vault) platform.
Serve as the primary TMF subject matter expert (SME) and go-to resource for study teams, Clinical Operations, Data Management, Regulatory Affairs, Biostatistics, Pharmacovigilance, and external CROs/vendors on all TMF-related questions, processes, and requirements.
Develop and maintain TMF management plans, filing strategies, and Expected Document List (EDL) configurations aligned to the DIA TMF Reference Model; review and monitor TMF metrics, KPIs, and quality indicators; perform routine TMF health checks and reconciliation activities.
Conduct TMF Quality Control (QC) reviews and periodic self-inspections; identify TMF risks, gaps, and misfiled or missing documents; drive root-cause analysis and implement corrective and preventive actions (CAPAs).
Maintain ongoing inspection readiness for all assigned studies; coordinate document retrieval and responses during sponsor audits and regulatory inspections (FDA, EMA, MHRA, and other health authorities); lead TMF remediation activities and inspection preparation exercises.
Ensure compliance with ICH-GCP (E6(R2)/(R3)), applicable FDA/EMA/MHRA regulations, and company SOPs governing TMF content, completeness, and timeliness throughout the trial lifecycle.
Configure and administer the Veeva Vault eTMF system for assigned studies, including user access/role management, metadata and document classification, workflow configuration, and support for system upgrades, migrations, or implementation projects.
Partner with Clinical Operations, CRAs, and CRO/vendor TMF counterparts to ensure timely, accurate transfer and filing of site, vendor, and trial-level documents; reconcile CRO-held TMF content against the Expected Document List and the company TMF.
Provide TMF training, guidance, and just-in-time coaching to study teams, new hires, and cross-functional stakeholders; facilitate study team meetings focused on TMF compliance and document management.
Track and report TMF workload, completeness, and quality metrics to management; proactively identify and escalate TMF risks and resourcing constraints, particularly given competing study priorities typical of a small biotech.
Contribute to the authorship and continuous improvement of TMF-related SOPs, work instructions, and job aids; drive adoption of TMF best practices across the organization.
Support the identification, assessment, and onboarding of TMF-related vendors/CROs, including participation in TMF-focused RFI/RFP activities and vendor eTMF interoperability assessments.
Independently prioritize and manage TMF deliverables across multiple concurrent studies with minimal supervision, exercising sound judgment in a resource-constrained, fast-paced small-biotech environment.
Additional tasks and projects as requested.
Bachelor's degree in life sciences or a related field; advanced degree a plus.
5-7 years of progressive clinical research experience in the biotechnology/pharmaceutical industry, with a significant focus on TMF operations/management.
Hands-on experience managing TMF from study startup through closeout and archival, including direct experience with the Veeva Vault eTMF system (required).
Working knowledge of the DIA TMF Reference Model (TMF RM) and Expected Document List (EDL) management.
Strong knowledge of ICH-GCP, FDA, EMA, MHRA, and other applicable global regulatory requirements governing TMF content and inspection readiness.
Demonstrated experience supporting sponsor audits and/or regulatory inspections, including TMF remediation.
CRO/vendor management experience, including oversight of TMF-related deliverables.
Experience in Ophthalmology and/or advanced (cell and gene) therapy studies in Phases 1-3 preferred.
Experience with CTMS, EDC, and RTSM a plus.
Demonstrated ability to work independently and resourcefully in a small biotech with competing priorities and limited resources.
Excellent cross-functional communication and collaboration skills; proven ability to serve as an SME and trusted go-to resource.
Outstanding attention to detail, organizational skills, and document/records management discipline.
Self-motivated with a strong commitment to quality, accuracy, and on-time deliverables.
Demonstrated ability to identify, escalate, and resolve issues, and to manage competing timelines
Critical skills and competencies
Veeva Vault eTMF platform expertise, including configuration, user/role administration, workflow, and metadata management (required, not just end-user experience).
Deep, practical knowledge of TMF content requirements across the full trial lifecycle: study startup, conduct, closeout, and archive.
TMF quality-control, completeness, and inspection-readiness methodology, including DIA TMF Reference Model application and Expected Document List reconciliation.
Regulatory inspection support experience (FDA/EMA/MHRA), including document retrieval and inspection-room readiness.
Risk-based thinking: proactive identification of TMF gaps and risks, with sound CAPA development and follow-through.
Cross-functional influence without direct authority - able to hold Clinical Operations, Data Management, Regulatory, Biostatistics, Pharmacovigilance, and CRO/vendor partners accountable to TMF timelines and quality standards.
Independent judgment and prioritization in a small-biotech, resource-constrained, multi-study environment with competing priorities.
SOP authorship and continuous-process-improvement mindset.
Training and mentoring skills - able to onboard and train study teams and new hires on TMF processes and expectations.
Strong digital literacy across eTMF, CTMS, EDC, and RTSM systems, with the ability to troubleshoot system and process issues.
Working Conditions
This position operates in an office setting and may include up to 10% travel to visit sites, vendors, or CROs, as applicable. This role may require the incumbent to be available outside standard hours to handle priority business needs, consistent with the demands of a small biotech.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.
The TMF Lead is an independently resourceful subject matter expert (SME) responsible for the quality, completeness, and inspection readiness of Trial Master Files (TMFs) across assigned clinical studies, from study startup through study closeout and archive, within the Veeva TMF (Vault) system. Operating in a small biotech environment with competing priorities, the TMF Lead works with minimal oversight, serving as the primary go-to resource for all TMF-related questions and driving TMF operational excellence in close collaboration with Clinical Operations, Data Management, Regulatory Affairs, Biostatistics, Pharmacovigilance, Quality Assurance, and external CROs/vendors, in adherence to company SOPs, ICH-GCP, and applicable regulatory requirements.
Responsibilities
Lead and own TMF activities across assigned clinical studies from study startup through closeout and archival, ensuring TMF completeness, quality, and continuous inspection readiness at every phase of the trial, within the Veeva TMF (Vault) platform.
Serve as the primary TMF subject matter expert (SME) and go-to resource for study teams, Clinical Operations, Data Management, Regulatory Affairs, Biostatistics, Pharmacovigilance, and external CROs/vendors on all TMF-related questions, processes, and requirements.
Develop and maintain TMF management plans, filing strategies, and Expected Document List (EDL) configurations aligned to the DIA TMF Reference Model; review and monitor TMF metrics, KPIs, and quality indicators; perform routine TMF health checks and reconciliation activities.
Conduct TMF Quality Control (QC) reviews and periodic self-inspections; identify TMF risks, gaps, and misfiled or missing documents; drive root-cause analysis and implement corrective and preventive actions (CAPAs).
Maintain ongoing inspection readiness for all assigned studies; coordinate document retrieval and responses during sponsor audits and regulatory inspections (FDA, EMA, MHRA, and other health authorities); lead TMF remediation activities and inspection preparation exercises.
Ensure compliance with ICH-GCP (E6(R2)/(R3)), applicable FDA/EMA/MHRA regulations, and company SOPs governing TMF content, completeness, and timeliness throughout the trial lifecycle.
Configure and administer the Veeva Vault eTMF system for assigned studies, including user access/role management, metadata and document classification, workflow configuration, and support for system upgrades, migrations, or implementation projects.
Partner with Clinical Operations, CRAs, and CRO/vendor TMF counterparts to ensure timely, accurate transfer and filing of site, vendor, and trial-level documents; reconcile CRO-held TMF content against the Expected Document List and the company TMF.
Provide TMF training, guidance, and just-in-time coaching to study teams, new hires, and cross-functional stakeholders; facilitate study team meetings focused on TMF compliance and document management.
Track and report TMF workload, completeness, and quality metrics to management; proactively identify and escalate TMF risks and resourcing constraints, particularly given competing study priorities typical of a small biotech.
Contribute to the authorship and continuous improvement of TMF-related SOPs, work instructions, and job aids; drive adoption of TMF best practices across the organization.
Support the identification, assessment, and onboarding of TMF-related vendors/CROs, including participation in TMF-focused RFI/RFP activities and vendor eTMF interoperability assessments.
Independently prioritize and manage TMF deliverables across multiple concurrent studies with minimal supervision, exercising sound judgment in a resource-constrained, fast-paced small-biotech environment.
Additional tasks and projects as requested.
Bachelor's degree in life sciences or a related field; advanced degree a plus.
5-7 years of progressive clinical research experience in the biotechnology/pharmaceutical industry, with a significant focus on TMF operations/management.
Hands-on experience managing TMF from study startup through closeout and archival, including direct experience with the Veeva Vault eTMF system (required).
Working knowledge of the DIA TMF Reference Model (TMF RM) and Expected Document List (EDL) management.
Strong knowledge of ICH-GCP, FDA, EMA, MHRA, and other applicable global regulatory requirements governing TMF content and inspection readiness.
Demonstrated experience supporting sponsor audits and/or regulatory inspections, including TMF remediation.
CRO/vendor management experience, including oversight of TMF-related deliverables.
Experience in Ophthalmology and/or advanced (cell and gene) therapy studies in Phases 1-3 preferred.
Experience with CTMS, EDC, and RTSM a plus.
Demonstrated ability to work independently and resourcefully in a small biotech with competing priorities and limited resources.
Excellent cross-functional communication and collaboration skills; proven ability to serve as an SME and trusted go-to resource.
Outstanding attention to detail, organizational skills, and document/records management discipline.
Self-motivated with a strong commitment to quality, accuracy, and on-time deliverables.
Demonstrated ability to identify, escalate, and resolve issues, and to manage competing timelines
Critical skills and competencies
Veeva Vault eTMF platform expertise, including configuration, user/role administration, workflow, and metadata management (required, not just end-user experience).
Deep, practical knowledge of TMF content requirements across the full trial lifecycle: study startup, conduct, closeout, and archive.
TMF quality-control, completeness, and inspection-readiness methodology, including DIA TMF Reference Model application and Expected Document List reconciliation.
Regulatory inspection support experience (FDA/EMA/MHRA), including document retrieval and inspection-room readiness.
Risk-based thinking: proactive identification of TMF gaps and risks, with sound CAPA development and follow-through.
Cross-functional influence without direct authority - able to hold Clinical Operations, Data Management, Regulatory, Biostatistics, Pharmacovigilance, and CRO/vendor partners accountable to TMF timelines and quality standards.
Independent judgment and prioritization in a small-biotech, resource-constrained, multi-study environment with competing priorities.
SOP authorship and continuous-process-improvement mindset.
Training and mentoring skills - able to onboard and train study teams and new hires on TMF processes and expectations.
Strong digital literacy across eTMF, CTMS, EDC, and RTSM systems, with the ability to troubleshoot system and process issues.
Working Conditions
This position operates in an office setting and may include up to 10% travel to visit sites, vendors, or CROs, as applicable. This role may require the incumbent to be available outside standard hours to handle priority business needs, consistent with the demands of a small biotech.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.