Position Summary
To act as the Functional Lead for Trial Master File (TMF) Services with responsibility for
delivery of all aspects of TMF.
Responsible for setup, maintenance and close of TMF.
Responsible for the complete and accurate Trial Master Files through documentation of
quality, consistency and timely filing across all assigned clinical trials, consistent with the
Trial Master File specifications, applicable SOPs, ICH/GCP guidelines, regulatory agency
and any other local authority requirements.
Responsible for ensuring that the Trial Master Files are submission/inspection ready.
Job Responsibilities
Recognize, exemplify and adhere to ICON's values which center around our commitment to
People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of
process improvement with a focus on streamlining our processes adding value to our business
and meeting client needs.
• Travel (approximately 5%) domestic and/or international.
• *Primary point of contact for the TMF of designated projects and responsible for developing
successful cross-functional relationships with internal and external stakeholders.
• *Lead the setup of the Study in TMF system.
• *Drive completeness and quality of TMF content for all assigned clinical trials until study close out.
• *Oversee documentation flow within projected timelines and determine course of actions to
prevent and remediate delays and errors.
• *Manage TMF activities in accordance with the contracted budget for TMF Operations.
• *Lead the development and implementation of the TMF specifications, such as process and
system changes.
• *Develop and foster sponsor relationships through effective TMF management and
communication.
• *Primary point of contact for internal and external audits of study TMF-related queries and support
the preparation of appropriate audit and inspection responses.
• *Effectively monitor and report on progress of the TMF to all stakeholders.
• *Facilitate communication and interaction among study team members from the set up until the
closing of the TMF for a clinical trial.
• Apply lessons learned to continuous improvement of documentation management practices
across study teams.
• *Provide education, feedback and guide Study Teams in order to build knowledge and awareness
of good document management practices and TMF for clinical trials.
• *Determine and review study specific TMF specifications to ensure quality and standardization is
established per program and kept up to date as program/protocols progress.
• *Assess impact of potential changes to TMF specifications prior to implementation; collaborate
with PM or equivalent if modifications are necessary.
• *Maintain Study Specific Document Lists (SSDLs) at the study, country and site levels by
collaborating with all relevant Functional Lines (e.g. Data Management, Clinical, Regulatory, etc.)
to ensure placeholders are correctly and accurately in place for the study and all versions and
instances are filed in a timely fashion.
• *Conduct periodic quality review of Study Specific Document Lists (SSDLs) at all levels and liaise
with the Functional Line Document Owners to ensure that all findings are addressed and
remediated in a timely manner.
• *Guide Study Team in the effective management of TMF when working with external vendors.
• *Enforce ownership and accountability of TMF documents across study teams. Ensure document
quality requirements are agreed to and met by the study team, according to Completeness,
Timeliness and Quality metrics.
• Participate in Company/Departmental initiatives, as requested.
• Mentor new employees in specified TMF Lead tasks and duties, if required
• Undertake other reasonably related duties as assigned.
Experience : Skills required
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the
essential functions.
• A minimum of 8+ years of clinical research industry experience in operations / Clinical
records management/ Regulatory/Quality or equivalent position/experience. Prior relevant experience in clinical operations / prior relevant experience in eTMF
management / clinical records management/ Regulatory/Quality or equivalent position/experience
• Clinical Operations /Clinical Documentation Management / Clinical Research industry experience in
order to have a thorough understanding of the processes associated with the conduct of clinical trials
and TMF operations.
• Have a general understanding of TMF documents (content/flow) generated by different departments.
• Possess a thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
• Outstanding verbal and written communications skills, combined with outstanding listening skills are
required.
• Computer literate, with experience working in clinical trial systems.
• Strong skills in negotiation and conflict resolution are essential. Ability to remain calm and focused in
high-stress situations is very important.
• History of achievement in a customer service role preferred, with demonstration of meeting customer
needs and concerns.
• History of achievement in building strong customer relationships.
• Experience supporting regulatory submissions and inspections preferred.
• Leadership and/or teaching abilities and experience are a plus.
• A sound knowledge of working across international boundaries and cultures.
• Due to the nature of this position it may be required for the employee to travel. Therefore, dependent
on the employee’s location, the employee may be required to possess a valid Driver’s license.
Qualification :
Any Life science degree
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