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TMF Consultant

Company: Green Key Resources
Location: Somerville
Posted on: January 15, 2022

Job Description:

Roles and ResponsibilitiesWorks cross-functionally across study teams.Liaisons between the clinical study teams, CRO staff, and eTMF vendor personnel.Project Manages deliverables and reconciles concerns for these teams.Monitors Quality Issue (QI) resolution specific to TMF findings.Attends and participates in study specific meetings.Contributes to TMF Health KPI tracking.Performs routine and ad hoc quality and/or completeness checks in the Trial Master File - focusing on identifying trends in completeness, quality, and timeliness.Contributes to TMF standardization and Risk-based QC efforts.Provides input into the development of Clinical Information Systems standards, policies, and procedures.Ensures that the use of systems adhere to all established policies, procedures, and standards.Works with Clinical Operations study teams to implement and promote best practices, standardizations, utilization, and optimization - keeping in mind TMF Health and Inspection Readiness.Provides timely support of TMF related business processes owned and driven by the Clinical Information Systems Team.Actively works to collect feedback to promote end user adoption, acceptance, and an active user community for the TMF.Experience, Education and Specialized Knowledge and SkillsMust thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. -Excellent interpersonal skills, ability to develop trusting relationships, good conflict management and negotiation skills. -Basic Qualifications2+ years' experience working in a clinical research (clinical operations) environment.Bachelor's degree required;Preferred QualificationsAdvanced degree preferred.Veeva Vault Clinical experience preferred.Experience working with the TMF Reference Model, understanding of regulatory documents and TMF Content.Experience with metrics, reporting, and/or business intelligence tools desired.

Keywords: Green Key Resources, Somerville , TMF Consultant, Professions , Somerville, Massachusetts

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