Role Description 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. - 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. Qualifications - 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. Requirements - 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. Company Description

Role Description 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. - 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. Qualifications - 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. Requirements - 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. Company Description

Role Description This role supports the DSNP clinical line of business by delivering reporting, analytics, and quality initiative support to improve clinical outcomes, operational efficiency, Model of Care performance, and STARS reporting requirements. The position provides advanced analytical insight, identifies data gaps, builds dashboards and reports, and partners closely with stakeholders across DSNP and Cardinal operations. This role functions as a bridge between clinical operations and IT, translating business and clinical needs into effective reporting and analytics solutions. The analyst will support pending report enhancements, DSNP–Cardinal reporting alignment, and large-scale program initiatives such as Circle of Care. Success in this role requires: - Strong communication - Stakeholder management - Ability to work independently - Support for high-level operational analytics and decision-making Qualifications - Bachelor’s Degree (Required) - Master’s Degree (Preferred) - No specific certification or licensure requirements Requirements - Minimum 3 years’ experience in healthcare — Required - Experience in project management and analytics — Required - Experience supporting DSNP, case management, or clinical program operations preferred - Experience working with reporting tools and dashboards; SQL exposure preferred - Demonstrated ability to translate operational needs into analytics/reporting solutions - Strong communication and stakeholder management experience across business and IT teams Benefits - Medical, Dental, Vision plans - Adoption, Fertility and Surrogacy Reimbursement up to $10,000 - Paid Time Off and Sick Leave - Paid Parental & Family Caregiver Leave - Emergency Backup Care - Long-Term, Short-Term Disability, and Critical Illness plans - Life Insurance - 401k/403B with Employer Match - Tuition Assistance – $5,250/year and discounted educational opportunities through Guild Education - Student Debt Pay Down – $10,000 - Reimbursement for certifications and free access to complete CEUs and professional development - Pet Insurance - Legal Resources Plan - Colleagues have the opportunity to earn an annual discretionary bonus if established system and employee eligibility criteria is met.

• Oversees clinical trial agreements, budgets, expenditures and payments for clinical studies • Ensures the timely execution of clinical research programs/protocols from conception through final clinical study report. This will generally involve close supervision of external contract organizations who will have responsibility for site interaction, site monitoring, data management, biostatistics, IRB interaction, central laboratory function, clinical research budget negotiation, medical writing, pharmacovigilance, and other critical activities • Establishes and maintains good working relationships with clinical study site personnel to ensure adherence to protocols and Good Clinical Practice (GCP), provision of quality data and adherence to study timelines • Maintains oversight of the conduct of the studies at the study centers (site selection, start up, monitor adherence to protocols and Good Clinical Practices (GCP), applicable guidance and study closure) • Key contributor to the preparation and management of clinical study protocols and protocol amendments • Assists with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc. • Contributes to the review of Investigator Sponsored Trials (ISTs) & the relevant documentation to support these trials. • Contributes to the creation of internal Iovance Biotherapeutics SOPs & Clinical work practice documents and implementation of these plans for Clinical Operations to operate in accordance with FDA & EMA regulations • Interfaces with Chief Medical Officer/Medical Monitor and cross-functional team members including Data Management, Drug Safety, Logistics/Manufacturing, Project Management, Regulatory Affairs, and Biostatistics • Provide direct supervision of Clinical Operations team members, including performance management and development planning • Serve as company representative at external meetings, scientific congresses, etc. • Perform miscellaneous duties as assigned.