Job Overview:
Remote
– Home Based Role
This position is responsible for CPS, ECD, Phase I-IV and observational trial master files (TMFs) as well as FSPx and Medical Device as assigned.
Serve as subject matter expert (SME) for the eTMF system and provides input for or participates in business improvement initiatives to drive quality, productivity and continuous improvement of eTMF system and processes.
Conduct TMF-specific Kick-off Meeting with Sponsor and Covance project team to establish expectations, requirements & deliverables in line with ICH and to support scope build Oversees planning, set-up, maintenance, QC and closure of the study TMF for clinical studies.
in accordance with agreed TMF processes (Covance or Sponsor SOPs) working with key study personnel as identified.
Confirms internal and external system access needs Accountable for the creation and maintenance of the TMF Plan and TMF Index.
Solicits input from Project Manager/Project Lead and Sponsor.
Remain current on Covance eTMF system training requirements.
Where needed, complete required eTMF system training for sponsor systems.
Provide project team training on study specific TMF plan and Index Ensure deviations from standard Covance TMF business process and operating model are documented accordingly in TMF Plan or other applicable document Enforce and escalate all identified compliance issues Monitor project scope and communicate any identified out of scope activity or requests to Project Lead.
Receive sponsor-specific report requests (confirm required, within scope).
Work with appropriate TMF Delivery Center team members to evaluate the feasibility of sponsor-specific report requests and ensure development and delivery sponsor-specific reports Oversees the preparation of the TMF for QA or Sponsor Audits and Inspections and participates in Audit & Inspections as required.
Responds to any CAPAs issued.
Maintains the TMF in a state of audit/inspection readiness by: Completing the Baseline Expected Document List (EDL) update for requiredness & count, working with key study personnel Manage ongoing “real-time” EDL maintenance per assigned study Oversee timely kick-off of TMF Review Workflows Monitor timely resolution of identified TMF Review Issues Responsible for monitoring completeness of the study TMF at each Milestone Review.
Escalates missing, incomplete, incorrect, inaccurate artifacts to the appropriate study team members.
Oversee the processing of essential artifacts required throughout all phases of the study in accordance with Covance SOPs, sponsor SOPs (as applicable), GCP, and ICH guidelines.
Attends Project Review/Governance debrief.
Reports on Portfolio and Study Level Key Performance Indicators (KPIs) as applicable, and monitors study metric compliance and provides remediation guidance as required.
Identifies trends per study and across programs; alerts management of trends as applicable Review and respond to TMF content quality issues Develop strategies for TMF Remediation when warranted Attend and/or present at internal or external study team meetings as required Maintain awareness of study events and the associated documentation requirements Maintains effective internal and external communication Is primary TMF Delivery Center point person for assigned studies.
Collaborates with all members of TMF Delivery Center Contributes overall client satisfaction Maintains an understanding of applicable regulatory requirements.
Manages TMF budget; which TMF Delivery Center Management support Performs other related duties as assigned Education/Qualifications: Required:
Associate’s (2-year) Degree, preferably with a Life Sciences/Business focus
Preferred:
Bachelor’s (4-year) Degree, preferably with a Life Sciences/Business focus
Equivalent experience within clinical research environment of 10+ years may be substituted for education requirements
Experience: Minimum Required: Minimum 3-5 years clinical research work experience or equivalent Minimum 4 years TMF experience required Understanding of FDA/EU and ICH – GCP regulations and guidelines Extensive working knowledge of the TMF Reference Model Demonstrated strategy for achieving TMF inspection readiness Extensive experience working in electronic trial master file systems Extensive experience of Microsoft Office products, web based applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs Demonstrated ability to lead by example and to encourage team members to seek solutions independently Demonstrated ability to handle multiple competing priorities and to utilize resources effectively Effective time management and organization skills Detail-oriented with a commitment to accuracy Excellent interpersonal, written and verbal communication skills Skilled in developing collaborative internal and external relationships Ability to negotiate and liaise with clients in a professional manner Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks Ability to mentor junior TMF Delivery Center team members Ability to present both internally and to clients Basic understanding of budget management and forecasting