Senior Clinical Records Specialist (TMF) - FSP / Sponsor Dedicated

Position Purpose:The Sr. Clinical Records Specialist is responsible for activities and systems related to clinical records and considers the operational and business needs of the Trial Master File.

Organizational Relationships:

• Reports to Parexel assigned Line Manager with day-to-day direction from the Client. • Liaises with cross functional lines as appropriate.

Primary Duties:

• Maintenance of Trial Master File (system or file room) which may include the following:

• Managing the controlled access process, including access training and monitoring
• Managing study file structure process and documentation
• Managing record archival and retrieval processes
• Scanning documents to support filing electronically
• Performing routine document quality control in the electronic file and conducting routine system tasks o Performing training cross-functionally to set expectations for filing in the Trial Master File

• Support internal and regulatory audits and inspections by making Trial Master File contents available as needed

• Lead Clinical Records projects as assigned, such as (but not limited to):

• Records retention, disaster/recovery o Quality reviews of Clinical Records processes to identify issues and implement solutions o Migrating paper-based studies to electronic Trial Master File
• Performing Trial Master File oversight in the form of periodic risk-based QC reviews on documents
• Participating in the development, implementation, and maintenance of electronic Trial Master File system and/or file room

• Primarily works and collaborates with supervisor, peers, and Trial Master File users across departments

• Identifies trends and escalates to the Trial Master File System Owner

• May determine methods and procedures on new assignments • May participate in system administration, subject matter expert (SME) and ad-hoc meetings to report on status, provide demonstrations of system functionality, and/or gather requirements for new or updated features

• Works under general supervision and on assignments that are moderately complex in nature where judgment is required in resolving routine problems and making routine recommendations

• Adhere to CFR, GCP/ICH, ALCOAC+CEA, company policies, Clinical Development Operations and project-specific quality documents (e.g., SOPs, work practices, training guides, defined Trial Master File key performance indicators) Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training

• Adheres to EP and Client SOPs and processes

Skills and Education:

• BS/BA or equivalent preferred

• A minimum of 2 years Trial Master File experience preferred within the pharmaceutical or biotechnology industry

• Familiarity with the DIA Trial Master File Reference Model structure

• Basic knowledge and understanding of CFR and GCP/ICH

• Proficiency with Microsoft Office Products - Word, Excel, PowerPoint, SharePoint (preferred)

• Fundamental understanding of filing systems and organizational tools

• Strong communication and inter-personal skills • Highly responsive and proactive, a team player

• Understanding of GCP principles, their importance, and how they apply to operational activities for this position