TMF Study Owner - FSP

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 global 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.

Job 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/Study Close-out

• Determines and reviews study specific TMF specifications to ensure quality and standardization are established per program and kept up to date as program/protocols progress.

  • Assesses impact of potential changes to TMF specifications prior to implementation and collaborates with PM or equivalent if modifications are necessary.

  • Maintains Study Specific Document Lists (SSDLs) at the study, country and site levels by collaborating with all relevant Functional Lines (e.g., Data Management, Clinical, Regulatory, etc.) to ensure placeholders are correctly and accurately in place for the study and all versions and instances are filed in a timely manner.

  • May support document processing per document QC checks and other reference documents.

• Supports the preparation of appropriate audit and inspection responses.

• Supports study team in the effective management of TMF when working external vendors.

• Analyzes error trends in documentation and provides feedback to the TMF Study Owner Leads and TMF Operations to enable continuous improvement.

• Supports study team to ensure document quality requirements are agreed to and met, according to Completeness, Timeliness and Quality metrics.

• Enforces ownership and accountability across study teams regarding readiness of TMF documents.

• Supports study team in addressing/reporting regulatory queries pertaining to document management.

• Supports study team in resolving TMF content issues.

• Ensures complete TMF is in place at time of study close/submission.

• Facilitates communication and interaction among study team members from the set up until the closing (e.g., TMF)

Qualifications:

Education

• Minimum of Bachelor’s degree or equivalent required

Prior Experience Preferred

• Experience/knowledg