Clinical Specialist Document

ICON plc • Blue Bell, SD

22h

About The Position

Clinical Document Specialist ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Document Specialist to join our diverse and dynamic team. As a Clinical Document Specialist at ICON, you will support the Clinical Operations department as the primary person responsible for supporting the Clinical Study Team (CST) with trial document management, conducting Quality Control checks (QC), and filing of documentation in the Veeva electronic Trial Master File (eTMF). This position will work closely with CST Functional Area Leads (FALs) and the Clinical Quality team.

Requirements

• Bachelor's Degree with 4+ years clinical experience including organizing and coordinating electronic Trial Master Files for clinical trials
• High level of competency with Veeva VAULT eTMF and knowledge of the TMF Reference Model, supported by DIA
• Excellent organizational and problem-solving skills, able to work independently
• Efficient and effective time management skills with ability to successfully manage competing priorities.
• Strong attention to detail

Responsibilities

• Support Clinical Operations and the CST with day-to-day lifecycle management of documentation including filing and classification of trial artifacts in the Veeva eTMF for clinical trials
• Serve as TMF contact and Subject Matter Expert for the clinical study team and supporting cross-functional departments including TMF process education to ensure high quality documentation
• Classify and index electronic TMF (eTMF) and clinical trial documentation with accurate attributes and metadata according to company standards, Good Clinical Documentation Practices, and project-level Trial Master File Plan and Index
• Monitor TMF health/report metrics throughout the study according to TMF plan and deliver KPI reports and dashboard to the study team
• Execute planned and ad hoc Quality Control (QC) procedures, identify and record quality issues; provide solutions and resolve issues with relevant FALs and in accordance with Alermes SOP ; identify documentation trends and perform corrective training to CST members as needed based on TMF QC findings
• Support audit/inspection activities, internal Compliance/Quality procedures and process improvement
• Execute change management to ensure consistent application and best practices of revised standards, processes, and systems functionality across Clinical Study Teams
• Develop, review, or update trial-level TMF Plans and Trial Index. Providing best practice guidance and support to ongoing and ad-hoc TMF projects and initiatives

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level