Job Description

Overview:

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The TMF Manager/Senior Manager is responsible for leading and managing the Trial Master File operations team to ensure high-quality, compliant, and efficient delivery of TMF services across clinical projects. Reporting to the TMF Director, this role provides operational oversight, supervises TMF staff, ensures adherence to SOPs, and supports continuous improvement in TMF practices to meet sponsor and regulatory expectations.


Responsibilities:
Lead day-to-day operations of the TMF team, ensuring compliance with SOPs, GCP, ICH, and applicable regulations. Supervise and mentor Leads, TMF Managers and Specialists, providing coaching, training, and performance evaluations. Oversee resourcing, workload management, and project assignments within the TMF group. Drive quality standards, ensuring timely CAPA resolution and effective audit/inspection readiness. Collaborate with cross-functional Clinical Operations teams to ensure consistent TMF processes and standards. Support training development and delivery for TMF staff, ensuring competency and compliance. Monitor operational metrics and ensure delivery against project timelines and sponsor requirements. Partner with Quality Assurance and PMO teams to address findings, mitigate risks, and implement process improvements. Provide input into proposals, budgets, and resourcing for new business opportunities related to TMF services. Represent TMF function in sponsor and internal project meetings, as needed Required Attributes

Qualifications:

Bachelor's degree required (scientific discipline preferred); Master's degree desirable. 7-10 years of progressive experience in Clinical Operations/TMF management within pharma, biotech, or CRO. Minimum 3-5 years supervisory/leadership experience managing TMF teams. Experience with audits, inspections, and regulatory submissions preferred Strong knowledge of TMF regulations, ICH E6 (R3), TMF Reference Model, and GCP. Proven leadership and people management skills, with ability to build effective teams. Strong organizational, planning, and problem-solving capabilities. Excellent communication and interpersonal skills, with ability to collaborate cross-functionally. Attention to detail, results-oriented mindset, and ability to thrive in a dynamic environment.

CONNECT WITH US!

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