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

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

TMF operationseTMF platformscomputer system validationSOP writing and revisionrecords managementTMF Reference ModelGood Clinical Practices (GCP)ICH GuidelinesKPI monitoringrisk-based QC processes

Soft Skills

leadershipproblem solvingdecision makingeffective communicationorganizational skillsattention to detailcollaborationself-directionmotivationtime management

Certifications

Bachelor's DegreeTMF Management certificationGCP certificationrecords management certificationclinical research certificationproject management certificationcompliance certificationdata protection certificationquality assurance certificationleadership training certification