Parexel FSP is seeking a TMF Study Owner to join our team in Argentina

Job Overview:
Trial Master File (TMF) Study Owner (SO) is:
- Subject Matter Expert to and single point of contact for the Project Manager (PM) or equivalent and study team to ensure a complete and accurate TMF through documentation quality and consistency across clinical trials and programs.
- Accountable to the PM or equivalent for all general Trial Master File responsibilities conducted internally as well as externally at preferred providers and Contract Research Organizations (CROs).
- To provide crucial TMF quality support to the study team and to establish a proactive quality-focused partner relationship with the study team.

Responsibilities:
- Contributes to the development and assists with the implementation of the TMF specifications, such as process and system changes.
- Leads the set-up of the TMF Study Specific Document List (SSDL) and monitors completeness and quality of TMF content for all assigned clinical trials until study close out.




- Ensures documentation flow is within projected timelines and determines course of actions to prevent and remediate timeline delays.
- Ensures consistent use of standardized processes and technologies across clinical trials and programs.
- Serves as point of contact for internal and external audits of study TMF-related queries.
- Actively identifies continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.
- Provides support and guidance to the study teams to drive performance against metric targets.
- Applies lessons learned to continuous improvement of documentation management practices across study teams.
- Provides education, feedback and support to study teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.
- Ensures that the program documentation supports the regulatory package requirements.

Clinical Study Start-up/Study Conduct/St

📌 Tmf Study Owner (Buenos Aires)
🏢 Parexel
📍 Buenos Aires