Job description

Senior TMF Oversight Specialist, Clinical Operations

Rockville, Maryland, United States

SR. TMF OVERSIGHT SPECIALIST, CLINICAL OPERATIONS

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

The Role:

The TMF Senior Oversight Specialist will lead and support for Trial Master File (TMF) activities to clinical study teams. This role will be responsible for the global oversight and day-to-day support of TMF activities, including setup and management of the TMF/eTMF, authoring, review, and approval of TMF Plans and other procedural documents, quality control (QC) and quality review of clinical documents, training on clinical document management and TMF business processes and the eTMF system, Veeva’s Vault, and vendor management and oversight of outsourced TMFs/eTMFs.They may mentor fellow TMF Oversight Specialist(s) and other study support staff (e.g., Clinical Trial Associates) and have direct reports (e.g., TMF Oversight Specialist(s)) ensuring their TMF deliverables 
are delivered to time, cost and quality.

Responsibilities:

  • Lead implementation and updating of processes initiatives for clinical document management and clinical trial records (e.g., Trial Master Files). 
  • Use audit and quality review findings to assess current status across programs, studies, countries, or sites to evaluate inconsistencies, gaps, and trends in compliance 
    of processes that might require process updates/improvements or re-training.
    o Apply knowledge of ICH-GCP, Code of Federal Regulations (CFR), and other national and local requirements to develop and improve document management processes. 
    o Collaborate with functional area representatives to help ensure submission-readiness and inspection-readiness of TMFs, as needed.
  • Create and lead training across all relevant business units/functional areas on business processes around Clinical Document Management and the Trial Master File, eTMF system(s), 
    and quality oversight of vendors.
  • Represent TMF Operations function on study teams.
  • Oversight of management and maintenance of document rooms, including supporting filing, scanning, QC, and inventory of paper documents.
  • Oversight of the transfer and archiving of study TMFs and associated records, as needed.
  • Conducting and supporting ongoing inspection readiness TMF checks throughout studies to assess compliance with study-specific and organizational processes and ICH-GCP and 
    applicable national and local regulations.
  • Authoring and reviewing internal and external TMF-related SOPs and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes, risk-based QC 
    processes, etc.) including working with the cross-functional study team to obtain necessary input.
  • Supporting internal and external audits and inspections including supporting study teams with locating and providing study documents, speaking to TMF processes, and assisting with addressing and resolving issues, as applicable. 
  • Management and maintenance of eTMF system, as needed. Including user account management, workflow management and oversight, as well as support for system updates, UAT and change control processes.
  • Provide oversight and management of eTMF associated vendors, as needed.
  • Lead TMF governance meetings with vendors to ensure oversight, compliance, and standardization across studies or programs.
  • Drive the development and reporting of metrics and KPIs related to inspection readiness, quality, TMF completeness, and performance.
  • Collaborate with study teams to help escalate and resolve issues identified as a result of quality reviews.
  • Ad hoc support of activities within Clinical Development to help meet timelines and objectives. This may include support with archiving, document collection and processing, or start-up activities.

Supervisory Responsibilities:

  • Manage supportive TMF Oversight function(s) (e.g., TMF Oversight Specialist(s)), by providing oversight and guidance of their task execution as required to ensure regulatory compliance of protocol activities, if appropriate.
  • Accountable for ensuring all study deliverables and milestones are met with quality and within timelines.
  • Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets.
  • Provide support/escalation point for direct reports as needed.

Qualifications: 

Essential

  • Thorough knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process.
  • End-to-end knowledge of clinical trials.
  • Knowledge and familiarity with industry workgroups and initiatives such as DIA Records Management Community (TMF Reference Model).
  • Knowledge of applicable TMF and Document Management regulations and guidelines such as MHRA and EMA.
  • General management and Vendor management experience.
  • Ability to work independently with minimal supervision and within global, cross-functional team matrices.
  • Proficiency in Microsoft Word, PowerPoint, Project, Excel, SharePoint, Adobe Acrobat, and TMF and/or
  • Document Management applications (e.g., eTMF, EDMS, etc.). Experience with other clinical systems preferred (e.g., CTMS, etc.

Experience with the following

  • Assisting with internal and Regulatory Authority inspections and Inspection readiness assessments with minimal guidance.
  • Presenting high level presentations, both orally and in writing using organizational skills to complement this.
  • Delivering open and honest constructive (positive and/or negative) feedback pertaining to work in hand independently.
  • Taking responsibility and ownership for entrusted tasks; seeing tasks through to completion and dealing with the consequences of failure or success.
  • Strong commitment to producing high-quality work with an attention to detail.
  • Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities. Handling disjointed tasks effectively. in a highly collaborative, multidisciplinary team setting.
  • Demonstrated ability to problem solve and use clear judgement in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.

Desirable 

  • Prior experience with the following would be an advantage:
    • Veeva Vault eTMF or other Veeva Vault platform applications.
    • Clinical operations (e.g., CTA, CRA/IH-CRA, Trial Manager, etc.) and/or clinical quality assurance (e.g., GCP auditor) background, with an interest in Trial Master File and Inspection Readiness.
    • Time management and organization skills.

Education & qualifications:

  • BA / BS, MS preferred.
  • At least 8 + years relevant clinical research (or related) experience in the biotechnology/pharmaceutical industry and/or clinical research organization with experience and knowledge of GCP environment and quality systems.
  • Demonstrated computer skills; proven functional knowledge of Microsoft packages and clinical systems.

Lead with Science and Discover What is Within:

  • We value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Medical benefits, beginning your first day of employment
  • Vision benefits
  • Fully paid Dental Insurance
  • 20 days’ vacation plus holidays
  • Fully paid Life Insurance and Disability
  • 401(k) with Company Match

Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.

Immunocore is an E-Verify employer.  

Applicants have rights under Federal Employment Laws:

Family and Medical Leave Act

Equal Employment Opportunity Commission

Employee Polygraph Protection Act

Uniformed Services Employment and Reemployment Rights Act (USERRA)

Right to work

EEO is the Law Supplement

Pay Transparency

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