TMF Study Owner - FSP

Parexel FSP is seeking a TMF Study Owner in Argentina!

Job Summary

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 assistswith the implementation of the TMF specifications,such as process and systemchanges.

• Leads the set-up of the TMF Study SpecificDocumentList (SSDL) and monitors completeness and quality of TMFcontentforallassignedclinicaltrialsuntilstudyclose out.

• Ensuresdocumentationflowiswithinprojected timelines and determines course of actions to prevent and remediatetimelinedelays.

• Ensuresconsistent use of standardizedprocesses and technologies across clinical trials and programs.

• Serves as point of contactforinternal and externalaudits of studyTMF-relatedqueries.

• Activelyidentifiescontinuousimprovementopportunities to enhanceoperationalefficienciesthroughprocess and metricsanalysis.

• Providessupport and guidance to the studyteams to drive performanceagainstmetrictargets.

• Applies lessons learned to continuousimprovement of documentationmanagementpractices across studyteams.

• Provideseducation,feedback and support to studyteamsinorder to buildknowledge and awareness of gooddocumentmanagementpractices and TMF forclinicaltrials.

• Ensures that the programdocumentationsupports the regulatory packagerequirements.

Clinical Study Start-up/Study Conduct/Study Close-out

• Determines and reviews study specific TMF specifications to ensurequality and standardization are establishedperprogram and kept up to date as program/protocolsprogress.

  • Assesses impact of potential changes to TMFspecificationsprior to implementation and collaborateswith PM or equivalentifmodifications are necessary.

  • MaintainsStudySpecificDocumentLists (SSDLs) at the study,countryandsitelevels by collaboratingwithallrelevantfunctionallines(e.g.,DataManagement,Clinical,Regulatory,etc.) to ensureplaceholders are correctly and accuratelyinplacefor the study and allversions and instances are filedin a timelymanner.

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

• Supports the preparation of appropriateaudit and inspectionresponses.

• Supportsstudyteamin the effectivemanagement of TMF whenworking external vendors.

• Analyzeserror trends indocumentation and provides feedback to the TMFStudyOwnerLeads and TMF Operations to enablecontinuousimprovement.

• Supportsstudyteam to ensuredocumentqualityrequirements are agreed to and met,according to Completeness,Timeliness and Quality metrics.

• Enforcesownership and accountabilityacrossstudyteamsregardingreadinessof TMF documents.

• Supportsstudyteaminaddressing/reportingregulatoryqueriespertaining to documentmanagement.

• SupportsstudyteaminresolvingTMFcontentissues.

• EnsurescompleteTMFisinplace at time of studyclose/submission.

• Facilitatescommunication and interactionamongstudyteam members from the set up until the closing(e.g., TMF)

Job Qualifications

Education

•        Minimum of Bachelor’s degree or equivalent required

Prior Experience Preferred

•        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 application types:

o       Electronic documentation management systems

o       Web based data management systems, as required

o       Database utilization

•        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.

•        History of achievement in negotiation and conflict resolution, and working in high-stress situations.