TMF Lead II (LATAM)

Precision Medicine GroupArgentina, Brazil + 4 more

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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

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TMF Lead II (LATAM)

Precision Medicine GroupArgentina, Brazil + 4 more

Apply now

Opens the original posting.

Apply now

Share job

Copy link or share on social media.

Apply on the original site

Companies in this catalog do not charge applicants. Never send money to apply.

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 Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

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 .

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 so we can investigate and take appropriate action.

Originally posted on Himalayas

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