Manager, Clinical Documenation
Rigel is a biopharmaceutical company dedicated to the discovery and development of novel, targeted drugs in the therapeutic areas of immunology, oncology and immuno-oncology. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. Our business strategy is to transition to a commercial-stage company with our Phase 3 results from fostamatinib in immune thrombocytopenic purpura (ITP), Rigel has submitted an NDA. We continue to build an extensive portfolio of products in immunology and oncology, monetizing select assets through attractive partnerships. The Regional Marketing Manager, Medical Marketing will be a key member of the Marketing department advancing Rigel’s commercial programs.
The Manager, Clinical Documentation will support all activities and processes necessary to ensure that the Trial Master File (TMF) is complete and inspection-ready for assigned studies. This position will contribute expertise on electronic Trial Master File (eTMF) software and processes, and will collaborate closely with Clinical Operations leadership to ensure that best-practice documentation procedures are implemented department-wide.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Clinical Trial Document Management:
- Manage the completeness and quality of the eTMF for assigned Rigel clinical studies throughout the TMF lifecycle.
- Work with study teams to ensure that the eTMF is ready for audits/inspections on an ongoing basis and at all times.
- Lead the development and implementation of study-specific eTMF procedures and plans to ensure quality standards and specifications are implemented and maintained throughout the course of assigned trials.
- Represent the company in CRO relationships to ensure TMF quality/completeness is maintained throughout assigned trials.
- Assist with managing SOP and procedural document revisions and approvals as delegated.
- Develop systems to document and demonstrate ongoing TMF auditing and assessment; report progress and any issues to responsible study team members, and work with study teams to close the loop on all issues.
- Support study teams to ensure document quality requirements and timelines are met.
- Resolve queries in the eTMF system pertaining to document management.
- Provide support and expertise to study teams on the TMF Management Processes and the eTMF system.
- Coordinate document projects; support regulatory submissions and due diligence efforts as needed.
- Participate in clinical operations initiatives and programs as assigned.
eTMF Vendor Management:
- Assist with managing eTMF vendor contracts and required access forms.
- Provide an interface to eTMF training and support for new and ongoing users.
- Evaluate metric reports to ensure progress is current and key deliverables are achieved per timelines.
- Coordinate with eTMF vendor for the planning and organization of the final and secure archiving of the eTMF (and paper records, if applicable).
- Support collaboration efforts with vendor to enhance processes and improve system efficiencies as needed.
- Lead or participate in TMF readiness checks/eTMF audits at key study milestones to assess compliance with agreed standards; identify gaps and provide recommendations for process improvements. Complete corrective actions in coordination with the study team.
- Participate in regulatory audits or inspections activities, as needed.
- Provide support with identifying, retrieving and providing any document requested by the inspector in a timely manner during an inspection.
- Contribute responses to audit/inspections of TMF findings and facilitate remediation of all TMF CAPA commitments.
eTMF System/Clinical Documentation Processes and Tools:
- Provide assistance in the development/review/implementation of relevant policies and procedures related to TMF management.
- Assist with the selection and management of appropriate technology support solutions and requirements for the changing landscape of TMF management.
- Contribute to the development of eTMF training materials.
- Maintain current on industry best practices; adjust standards where necessary to ensure compliance and to enhance efficiencies where needed.
TMF Legacy Management:
- Support off-site storage activities for legacy clinical trial documents in accordance with corporate policy.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Bachelor’s Degree or equivalent knowledge and skills as acquired.
- At least 3-5 years of experience in Trial Master File management or eTMF operations in the pharmaceutical industry with a minimum of 5 years’ experience in clinical documentation
- Excellent working knowledge of DIA TMF Reference Model.
- Strong working knowledge of ICH/GCP documentation requirements.
- Advanced knowledge of eTMF systems and reporting capabilities.
- Excellent computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
- Working knowledge and experience with electronic records management and related computer technologies, including electronic signatures and records.
- Self-motivated and able to work independently or in a group setting as required.
- Ability to gain and establish cooperative relationships and work effectively with all levels of personnel on records management issues.
- Excellent organizational and problem-solving skills.
- Effective time management skills and ability to manage competing priorities.
- Excellent communication skills (verbal, written, and presentation).
- Good working knowledge of ClinicalTrials.gov requirements.