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 for delivery of TMF-related goals.
Manages, trains, and mentors/coaches TMF SOs and/or document processing staff to ensure completeness, consistency, compliance of TMF for assigned clinical trials from study start to study close/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 process standards and system upgrades/enhancements.
Works closely with the TMF Operations Head and Leads formulating strategies and specifications to be implemented for all clinical trials and programs in scope (i.e., interventional).
Creates, maintains and assumes accountability for a culture of high-customer service using tools to facilitate communication, transparency of operations, clarity of workload balance, and alignment within and across functional lines.
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 all document management activities are conducted in compliance with GCP, relevant standards (e.g., SOPs, etc.) and regulatory requirements.
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 assist with the implementation of the TMF specifications, including TMF document specifications, 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.
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