Parexel FSP is seeking a **TMF Study Owner Lead** in Argentina! **Job Summary** The **Trial** **Master** **File** **(TMF)** **Study** **Owner** **(SO)** **Lead** provides managerial oversight of document management deliverables of assigned TMF Study Owners (SOs) and/or document processing staff (e.g., TMF Study Owner Associates, TMF Document Specialists). The TMF SO Lead: + Is accountable to TMF Operations LT fordelivery of TMF-relatedgoals. + Manages,trains, and mentors/coachesTMFSOs and/or document processing staff to ensure completeness,consistency,compliance of TMFforassignedclinical trials from study start to studyclose/submission. + Serves as Subject Matter Expert for TMF process, systems and related tools. + Is the primary point of issue escalation for assigned TMF SOs and/or document processing staff. + Contributes to the implementation of new and revised TMF processstandards and systemupgrades/enhancements. + Works closelywith the TMF Operations Head and Leadsformulatingstrategies and specifications to be implementedforallclinical trials and programsin scope (i.e.,interventional). + Creates,maintains and assumesaccountabilityfor a culture of high-customerservice using tools to facilitatecommunication,transparency of operations,clarity of workload balance, and alignmentwithin and acrossfunctionallines. **Job Responsibilities** + Provide oversight in the following areas: administrative and organizational activities, process and technology activities related to document management. + Implement organizational design, identify resource needed to support portfolio, coordinate recruitment and develop staff succession planning. + Provide and/or arrange training, coaching and mentoring via initiatives such as new hire orientation, technical and soft skills training, knowledge sharing, cultural enhancement, etc. + Ensure that alldocumentmanagementactivities are conductedincompliance with GCP,relevantstandards(e.g.,SOPs, etc.) and regulatoryrequirements. + Implement strategies to ensure consistent processes are executed in strong collaboration with TMF Operations LT and associated Sponsor`s R&D functions. + Review metrics to monitor performance against targets to ensure program deliverables are being met and productivity is aligned with sponsor`s expectations. + Identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis. + Contribute to the development and assistwith the implementation of the TMFspecifications,includingTMFdocumentspecifications,taxonomy and metadata. **Job Qualifications** **Education** • Minimum of Bachelor’s degree or equivalent required. Advanced degree is preferred. **Prior Experience Preferred** • 3 to 5 years’ experience in clinical trial management role, such as Project Manager, Study Manager, Trial Master File management role, such as TMF Study Owner, or an equivalent role. • Previous experience leading a group responsible for clinical document management and/or clinical study management function or equivalent. • Experience in management of medical/clinical study records and documentation. • Experience/knowledge of ICH/GCP documentation requirements. • Clinical documentation management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations. • Experience with the following applications types: o Electronic documentation management systems o Web based data management systems, as required o Database utilization • Extensive knowledge of vendor processes and best practices in document management. • Experience supporting the documentation components of regulatory submissions and inspections preferred. • History of achievement in a customer service role with demonstration of meeting customer needs and concerns. • Strong background in provision of high levels of customer service evidenced by positive feedback from customers. • History of achievement in building strong customer relationships. • Experience of working across international boundaries and cultures. • Previous experience managing staff across locations preferred. • History of achievement in negotiation and conflict resolution and working in high-stress situations. \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.