Job Description

SUMMARY:

Responsible for assisting and providing support to the entire Inspection Readiness Project Team Members e.g., NDA and Inspection Readiness Lead, GCP documentation specialist, Clinical Project/Trial Managers, Regulatory, etc.) in the management of all TMF related activities including the planning and execution of in-house or outsourced TMF activities. The ADS and will be responsible for continuous review of the TMF to ensure that the TMFs are inspection ready. The ADS performs work within established study protocols under supervision from the Inspection readiness lead or designees.

RESPONSIBILITIES:

• Conducts quality control and/or completeness checks, in accordance with internal SOPs and operational best practices relating to document management, to ensure accuracy of files within TMFs; Support the review of document quality data and audit outputs
• Assists in creation, maintenance and archival of Trial Master Files/ eTrial Master Files in accordance with internal Standard Operating Procedure (SOP), GCP, EMA and FDA regulations
• Assists Inspection Readiness Team and Clinical Project/Trial Manager in tracking eTMF related activities/milestones/metrics
• Runs eTMF metrics for project teams; follows up with vendor/ project teams if required
• Assists/supports project teams with preparation for audits/inspections (internal and external)
• Develops TMF knowledge with progression towards subject matter expert for eTMF systems
• Under supervision of Inspection Readiness project team members, may assist with tasks typically associated with GCP Documentation Specialist study such as site visits, CRA management, clinical document/ report review, ICF template generation and/or review, review IMP release packet prior to initiation, etc.
• Serve as key point of contact together with SME for internal and external teams regarding TMF related processes and activities.
• Assists in the collaboration with the internal cross-functional project team and vendors to resolve discrepancies and ensure timely completion of internal tasks, as they relate to TMF deliverables.
• Collects & collate documents required for eTMF submissions; track, name, scan/upload, code, file, and retrieve documents as requested for project team members if required
• Maintains a working knowledge and ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements, internal SOPs and study-specific procedures.
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics)
• Maintain up to date training records per internal SOPs, processes and procedures
• Take on career developmental activities/tasks as necessary.

QUALIFICATIONS:

• Bachelor's degree or nursing qualification is required. Scientific/health care field
• preferred, but not required.
• Minimum of 3 years experience in use of eTMF system (e.g. clinical site, CRO, Sponsor or clinical trial vendor).
• Comfortable with technology and ability to learn new systems quickly.
• Relevant experience in clinical research (clinical operations and/ or QA preferred) or related field.
• Exposure to current regulatory requirements and guidelines governing clinical research and GCP
• Working knowledge of MS Word, Excel, PowerPoint and Outlook.
• Requires attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
• Must be able to professionally interact and communicate with visitors, vendors and individuals at all levels of the organization.
• Must be able to work in a fast-paced environment with demonstrated ability to appropriately prioritize competing tasks and demands.
• Ability to work proactively and successfully within a cross-functional team.

Company Description

Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.