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Associate Director, TMF Management

DirectorDirectorOtherRemoteSeniorTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

121 days ago

Salary

$170K - $185K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglishGCPHashiCorp Vault

Job Description

Associate Director, TMF Management

Apogee Therapeutics

• Provide leadership and act as a Subject Matter Expert (SME) for TMF operations and requirements across study team functions, CROs, and vendors to ensure TMF content is timely, complete, and of the highest quality for in-house and outsourced studies • Build and maintain collaborative relationships with cross-functional partners, CROs, and external vendors to ensure expectations are clear, deliverables are met, and issues are resolved in a timely manner • Serve as an escalation point for study teams to drive resolution of issues, as appropriate • Ensure compliance with TMF Management SOPs, Good Documentation Practices (GDocP), ALCOA-CCEA principles (i.e. records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available), applicable regulations, GCP requirements, and industry standards • Monitor and report KPIs to senior management, identifying trends across the portfolio, areas for improvement, and implementing changes as needed • Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required • Responsible for the management and leadership of a team of direct reports that will support the eTMF platforms and each study TMF including recruitment, training, mentoring, career development, work assignments, performance evaluations, and ongoing feedback • Assist with development and implementation of TMF processes, procedures, supporting tools, and TMF-related training materials that adhere to regulatory requirements and industry best practices • Review external TMF-related SOPs and associated documentation as needed • Author and review TMF Plans and associated documentation (e.g., TMF indexes/mapping, risk-based QC processes etc.), working with the cross functional study team to obtain necessary input • Oversee study teams in TMF closeout activities, including collection of study records from all vendors, end of trial TMF QC, and migration activities, if applicable • Oversee archiving activities to ensure adherence to processes and industry best practices • Ad hoc support of activities within the Clinical Operations team to help meet timelines and objectives including support with start-up activities, record collection and processing, QC, and/or archiving, as needed • Collaborate on projects with Information Technology (IT) to ensure effective implementation and integration of eTMF clinical systems • Lead and manage resolution of issues and remediation activities with stakeholders and the eTMF vendor • Serve as eTMF Business Owner and Administrator • Support integration of partnered or clinical information including TMF transfers in compliance with applicable regulations and best practice • Provide eTMF system training and acts as a primary support for users and study teams • Assist management with identifying areas of improvement and enhancements and obtains approval for system development projects

Job Requirements

  • Bachelor's Degree or higher
  • 10+ years of experience successfully leading the TMF activities for clinical research/ biotech/pharmaceutical
  • Experience with Veeva Vault eTMF platform, strongly preferred
  • Experience with implementation and integration of eTMF platforms
  • Experience with computer system validation/assurance
  • Experience in managing direct reports and leading teams to execute projects
  • Knowledge of the principles and practices of traditional records management as applied to the pharmaceutical/ biotech or contract research organization industry
  • Comprehensive knowledge of TMF Reference Model, regulations, Good Clinical Practices (GCP), and ICH Guidelines
  • Strong software and computer skills, including Microsoft Office applications (Outlook, Word, Excel & PowerPoint)
  • Relevant experience in processing, archiving, and retrieving records in electronic format
  • Experience with writing and revising SOPs related to eTMF systems
  • Knowledge of relevant licensing and industry compliance regulations
  • This role necessitates self-direction, motivation, problem solving and decision-making abilities
  • Demonstrated effective written and verbal communication skills with internal and external team members, and functional leadership
  • Able to lead initiatives and communicate effectively through presentations for external and internal audiences
  • Excellent organizational skills with outstanding attention to detail and follow through
  • Able to successfully manage/prioritize multiple projects with limited direction from manager
  • Able to navigate complex problems, develop advanced concepts, make decisions, anticipate challenges, and propose solutions/recommendations
  • Able to collaborate with the vendor on on-going system issues, upgrades, and maintenance
  • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
  • Position requires up to 10% travel including mandatory in-person attendance at All Hands Meetings typically held twice per year

Benefits

  • A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
  • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
  • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
  • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
  • Commitment to growing you professionally and providing access to resources to further your development
  • Apogee offers regular all team, in-person meetings to build relationships and problem solve

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