Sr. TMF Lead

Alimentiv

10d•Remote

About The Position

Alimentiv is a global CRO focused on advancing therapies for gastrointestinal diseases. The Sr. TMF Lead provides expert, study-facing TMF oversight for assigned studies and complex programs, ensuring TMF quality, compliance, and continuous inspection readiness. This role acts as a TMF subject matter expert (SME), aligning sponsor-specific TMF requirements with CRO processes, applying risk-based TMF management practices, and leading TMF execution from study start-up through close-out. The Sr. TMF Lead independently advises sponsors and internal stakeholders, mentors TMF staff, and contributes expertise to TMF process and system improvements. This position is open to candidates residing in Germany, Brazil, Poland, Hungary, and Romania, with a closing date of June 12th, 2026, or until a successful candidate is identified.

Requirements

Minimum 7-9 years of recent, related experience in TMF function within a Contract Research Organization
Honour's Bachelor's degree or equivalent combination of education and experience
Strong working knowledge of ICH-GCP, 21 CFR Part 11, EU CTR, and other global regulatory requirements
TMF Reference Model and risk-based TMF management principles
Experience with inspection readiness activities (FDA, EMA, MHRA, etc) and TMF audits
Procedural gap analysis and issue resolution in TMF contexts
Experience with leading eTMF platforms (e.g., Veeva Vault, Wingspan)
TMF governance, quality oversight, and inspection readiness
Strong organizational, analytical, and problem-solving skills
Excellent stakeholder management, communication, and client-facing skills
Ability to work effectively in a global, matrixed environment
Program-level or portfolio TMF oversight experience, including study alignment and risk management within a sponsor or CRO environment
Demonstrated ability to advise sponsors and cross-functional stakeholders on TMF strategy and risk management
Continuous improvement mindset and ability to provide study-level process guidance

Nice To Haves

Certifications related to clinical research, quality, or regulatory compliance (e.g., SOCRA, ACRP, RAPS, TMF certification) would be an asset

Responsibilities

Serve as TMF Lead for complex, high-risk, or strategically important studies or programs.
Provide end-to-end TMF oversight from study start-up through close-out, transfer, and archival.
Utilize TMF metrics, KPIs, and risk-based assessments to monitor TMF health and inspection readiness.
Partner with Project Management and Functional Leads to proactively manage TMF deliverables and risks.
Ensure TMF oversight reports and status updates are delivered to sponsors and internal stakeholders on a defined cadence.
Lead study-level audit and inspection readiness activities and support audit responses.
Provide strategic, study-facing oversight across assigned studies, programs, or product lines to ensure consistent TMF execution.
Align sponsor-specific TMF requirements with CRO processes and filing models, ensuring clear expectations for study teams.
Utilize TMF metrics, KPIs, and risk-based assessments to ensure TMFs meet standards for quality, completeness, timeliness, and inspection readiness.
Identify cross-study or systemic trends and risks; develop and drive mitigation strategies, corrective actions, and targeted training initiatives.
Act as TMF SME for TMF Management Plans, file and guidance.
Support sponsor-facing TMF strategy discussions and governance forums.
Act as escalation point for complex TMF risks and compliance issues.
Ensure consistent application of TMF processes, standards, and quality expectations across assigned studies.
Identify study-facing process gaps, inefficiencies, or compliance risks and escalate recommendations to TMF Operations (TMFO) and Quality.
Contribute subject matter expertise to TMF process updates, SOP revisions, and system enhancements led by TMFO.
Support implementation of updated TMF processes, tools, and system changes within study teams.
Provide advanced mentoring and TMF oversight guidance to TMF Leads, TMFAs, and TMFCs to ensure consistent application of TMF standards.
Develop and deliver advanced TMF training materials for study teams and functional stakeholders.
Partner with Quality Training & Compliance (QTC) to ensure training reflects current processes and inspection expectations.
Serve as a knowledge resource for complex TMF scenarios, regulatory expectations, and inspection readiness.