TMF Lead II (LATAM)

<p></p> <p style="margin: 0in;"><span style="font-family: Calibri; font-size: 11.0pt;">We’re expanding across&nbsp;</span><span style="font-weight: bold; font-family: 'Untitled Sans'; font-size: 12.0pt; ">Mexico, Brazil, Argentina, Colombia, Chile, and Peru</span><span style="font-family: Calibri; font-size: 11.0pt;">, 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!</span></p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;">&nbsp;</p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;">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.</p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;">&nbsp;</p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><span style="font-weight: bold;">Responsibilities:</span></p> <ul style=" margin-top: 0in; margin-bottom: 0in;" type="disc"> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">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</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">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</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Ensure that TMF documentation (e.g. TMF Plan, TMF Index, Periodic Quality Review documentation) is filed in the TMF</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">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</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">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</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Ensure that TMF Risks are identified and appropriately documented and mitigated</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Monitor and report on TMF Health and Metrics and escalate non-compliances and potential issues to internal team and Senior Leadership as required</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Identify trends, risks, and overall status of the TMF and suggest mitigation strategies</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Support Audits and Inspections and finding resolutions and participate in Audit/Inspection interviews with support and oversight from Line Management</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Ensure that Periodic Quality Review for assigned projects is initiated and performed by the Quality Review Specialists and ensure proper documentation</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Ensure that document review and processing for assigned projects is performed by the Document Specialists on a timely and consistent basis</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Identify project team TMF training needs and provide or support team re-education</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">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</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Where needed, manage projects within the Sponsor eTMF System</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Monitor and report potential out of scope activities related to Records Management and communicate this to TMF manager for support</span></li> </ul> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;">&nbsp;</p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><span style="font-weight: bold;">Minimum Education &amp; Experience: </span></p> <ul style=" margin-top: 0in; margin-bottom: 0in;" type="disc"> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Bachelor’s degree (or its international equivalent) </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">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.</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Professional working proficiency in English</span></li> </ul> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;">&nbsp;</p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><span style="font-weight: bold;">Knowledge, Skills, and Competencies:</span></p> <ul style=" margin-top: 0in; margin-bottom: 0in;" type="disc"> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint) </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Experience with eTMF systems and vendors </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Working knowledge of FDA &amp; ICH/GCP regulations and guidelines </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Demonstrates solid interpersonal skills </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Ability to identify issues and escalate appropriately and effectively </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Good organizational skills, time management, and ability to coordinate workload and meet established deadlines </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Communicates both verbally and in written form in an efficient and professional manner </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Demonstrates values and a work ethic consistent with Precision Values and Company Principles </span></li> </ul> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;">&nbsp;</p> <p style="margin: 0in; font-family: Calibri; font-size: 10.0pt; color: black;">#LI-AG2 #LI-REMOTE</p> <p></p><div class="content-conclusion"><p>Any data provided as a part of this application will be stored in accordance with our <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&amp;data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&amp;reserved=0">Privacy Policy.</a>&nbsp;For CA applicants, please also refer to our&nbsp;<a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&amp;data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&amp;reserved=0">CA Privacy Notice</a>.</p> <p>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.</p> <p>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&nbsp;<a href="mailto:QuestionForHR@precisionmedicinegrp.com">QuestionForHR@precisionmedicinegrp.com</a>.</p> <p>It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.</p></div>