TMF Study Owner Lead - FSP

Parexel FSP is seeking a TMF Study Owner Lead in Argentina!

Job Summary

TheTrialMasterFile(TMF) Study Owner(SO)Leadprovides managerialoversight of documentmanagementdeliverables of assigned TMF Study Owners (SOs) and/or document processing staff (e.g., TMF Study Owner Associates, TMF Document Specialists).TheTMFSO 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.