Precision AQ

Data-driven drug access and launches

Trial Master File Lead 2

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeNo salary listed

About the Job

Requirements

A bachelor's degree or its international equivalent is required.
A minimum of 3 years of related experience is required, or an equivalent combination of education, professional training, and experience that provides the knowledge, skills, and abilities needed for the job.
Professional working proficiency in English is required.
Established experience and fluency with Microsoft Office programs, including Outlook, Word, Excel, and PowerPoint, is required.
Experience with electronic Trial Master File (eTMF) systems and vendors is required.
Working knowledge of FDA and International Council for Harmonisation/Good Clinical Practice regulations and guidelines is required.
The candidate must be able to identify issues and escalate them appropriately and effectively.
The candidate must have organizational and time-management skills and be able to coordinate workload and meet established deadlines.
The candidate must demonstrate, or be able to learn and retain, working knowledge of ICH-GCP, relevant Precision standard operating procedures, and regulatory guidance.
The candidate must be able to work and plan independently as well as in a team environment.
The candidate must communicate verbally and in writing in an efficient and professional manner.

Responsibilities

Ensure timely, high-quality review and processing of TMF documents; periodic quality review; setup, maintenance, finalization, and archival of study TMFs.
Create and execute the study TMF Plan and project TMF Document Index; ensure the study team understands expectations and project-specific TMF requirements; communicate changes to the plan or index to the project team.
Ensure TMF documentation, including the TMF Plan, TMF Index, and Periodic Quality Review documentation, is filed in the TMF.
Attend and contribute to project kick-off, internal, external, and ad hoc meetings to update the project team on TMF status, potential gaps, and escalations.
Collaborate with the Project Manager and Functional Leads to ensure timely, high-quality submission of TMF documentation and maintain the TMF in an inspection-ready state.
Identify TMF risks and ensure they are documented and mitigated appropriately.
Monitor and report TMF health and metrics, and escalate non-compliances and potential issues to the internal team and Senior Leadership as required.
Identify TMF trends, risks, and overall status, and suggest mitigation strategies.
Support audits and inspections and resolution of findings, and participate in audit or inspection interviews with support and oversight from Line Management.
Ensure periodic quality reviews for assigned projects are initiated and performed by Quality Review Specialists and properly documented.
Ensure Document Specialists perform document review and processing for assigned projects on a timely and consistent basis.
Identify project-team TMF training needs and provide or support team re-education.
Manage study close-out activities, including defining timelines for final document submission, final document processing, and closing outstanding queries; request eTMF exports from vendors; transfer them to sponsors; and collect acknowledgements of receipt.
Manage projects within the sponsor eTMF system when needed.
Monitor and report potential out-of-scope Records Management activities and communicate them to the TMF Manager for support.

Desired Qualifications

The candidate should demonstrate solid interpersonal skills.
The candidate should demonstrate self-motivation, attention to detail, and professionalism, including punctuality, delivering on commitments, and maintaining positive interactions with internal and external stakeholders.

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for an experienced Trial Master File TMF Lead II to help build the foundation of this new regional function in LATAM!

Our TMF Lead II is responsible for supporting project teams in maintaining a high quality Trial Master Files in accordance with Good Clinical Practice (GCP), other guidance documents, and Precision Standard Operating Procedures (SOPs). The TMF Lead II supports a range of studies across the Precision Medicine Group portfolio.

Responsibilities:

Ensure that TMF document review and processing, periodic quality review, set up, maintenance, finalization and archival of study TMFs is completed in a timely manner and with a high level of quality
Create and execute the study TMF Plan and project TMF Document Index. Ensure entire study team understands expectations, project-specific aspects of the TMF, and manage communication of any changes in the TMF Plan or Index to the project team
Ensure that TMF documentation (e.g. TMF Plan, TMF Index, Periodic Quality Review documentation) is filed in the TMF
Attend and contribute to project kick-off meetings, project internal or external meetings, and ad hoc meetings as needed to ensure the project team is aware of the status of the TMF, potential gaps and escalations
Engage and collaborate with the Project Manager and Functional Leads to ensure TMF documentation is submitted in a timely manner and with high quality in order to maintain the TMF in an inspection-ready state
Ensure that TMF Risks are identified and appropriately documented and mitigated
Monitor and report on TMF Health and Metrics and escalate non-compliances and potential issues to internal team and Senior Leadership as required
Identify trends, risks, and overall status of the TMF and suggest mitigation strategies
Support Audits and Inspections and finding resolutions and participate in Audit/Inspection interviews with support and oversight from Line Management
Ensure that Periodic Quality Review for assigned projects is initiated and performed by the Quality Review Specialists and ensure proper documentation
Ensure that document review and processing for assigned projects is performed by the Document Specialists on a timely and consistent basis
Identify project team TMF training needs and provide or support team re-education
Manage the close-out activities of assigned studies, including defining the timeline for final document submission, final document processing, close out of all outstanding queries, requesting the eTMF export from the vendor, transfer to the sponsor and collect the Acknowledgement of Receipt
Where needed, manage projects within the Sponsor eTMF System
Monitor and report potential out of scope activities related to Records Management and communicate this to TMF manager for support

Minimum Education & Experience:

Bachelor’s degree (or its international equivalent)
A minimum of 3 years of related experience Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.
Professional working proficiency in English

Knowledge, Skills, and Competencies:

Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
Experience with eTMF systems and vendors
Working knowledge of FDA & ICH/GCP regulations and guidelines
Demonstrates solid interpersonal skills
Ability to identify issues and escalate appropriately and effectively
Good organizational skills, time management, and ability to coordinate workload and meet established deadlines
Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance
Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders
Communicates both verbally and in written form in an efficient and professional manner
Demonstrates values and a work ethic consistent with Precision Values and Company Principles

#LI-AG2 #LI-REMOTE

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [email protected] so we can investigate and take appropriate action.

Candidates must be legally authorized to work in the country of employment without employer sponsorship.

About the Company

Precision AQ

Data-driven drug access and launches

Precision AQ helps pharmaceutical companies get FDA-approved medicines to patients by using data, evidence, and market insights to shape access and launches. Its services combine medical science, commercial strategy, and technology development to create new pathways for drug availability and timely delivery. The company partners with drug makers to plan launches and expansion, using analytical and creative approaches to make medicines reachable and effective in real-world settings. Unlike firms that focus only on science or marketing, Precision AQ blends data-driven insights with strategic execution across development and commercialization to accelerate patient access. The goal is to raise standards in healthcare accessibility and impact by getting the right medicines to the right patients faster.

Company size: 501-1,000
Company stage: Not listed
Total funding: Not listed
Headquarters: New York City, New York
Founded: Not listed

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