This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Catalyst Standard Operating Procedures (SOPs) as appropriate. The Senior Clinical Document Specialist will support the TMF and Master Control content owners on several programs. This position will ensure that the TMF is kept both current and inspection ready according to applicable regulations, and the Master Control document management system is maintained. This role is also responsible for being pivotal point of contact for the Clinical Operations and Regulatory teams, and any Contract Research Organizations (CROs) used.

Responsibilities:

• Work directly with TMF and Master Control (MC) Content Owners to identify issues, perform completeness checks, and upload documents
• Support the management and oversight of the vendor of study-specific trial master files
• Support the coordination of the transfer of study-specific trial master files from a CRO
• Acting as TMF/MC subject matter expert(SME)/point of contact for study teams and TMF/MC stakeholders, including attending study team/regulatory meetings
• Review andfy documents collected from internal and external sources
• Reconcile essential documents to avoid duplication
• Support study teams with the TMF quality review process
• Perform QC and maintenance of eTMF for assigned studies
• Perform data uploads and reconciliation
• Lead or provide input on revision of TMF related work instructions and SOPs
• Lead or provide direct TMF support to clinical trial activities including managing study expected document lists in eTMF
• Lead or support follow up on quality findings
• Provide training and mentoring activities for new and current staff
• Ensure the eTMF is maintained with an inspection-ready strategy
• Performs and documents interim, and close-out eTMF audits when requested
• Work cross-functionally with internal departments and external resources (e.g., CROs, partners, etc.) to resolve gaps in the eTMF
• Develop metrics, reports, and TMF tools/trainings
• Support the study team in audit, inspection readiness preparation and inspection activities
• Ability to function at a high level in a team setting whether as group contribution or acting as an individual contributor
• Position may require occasional travel

Requirements:

• Bachelor's degree and 4-6 years of professional clinical document management experience
• Demonstrated knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
• Experience with electronic trial master file system(s) including uploading, reviewing, quality checks (QC), approval of study required documents.
• Working knowledge of DIA reference model
• Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable
• Good communication and interpersonal skills
• Good time management skills, excellent attention to detail, and ability to multi-task in a high volume environment
• Team oriented and flexible; maintaining integrity and high ethical standards