SRG is looking for a Director, eTMF Management & Inspection Readiness to join our client's Pharmaceutical Manufacturing team!

Location Requirements: Fully Remote! East Coast Hours

Contract: W2 plus benefits (No C2C at this time)

Duration: 12+ months - long term contract!

Qualifications

• 8-12+ years of clinical research experience, including significant TMF/eTMF leadership experience
• Proven experience in building and leading TMF frameworks in an outsourced or hybrid operating model
• Deep expertise in TMF strategy, governance, inspection readiness, and health authority inspections (FDA, EMA)
• Strong knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirements
• Extensive experience with eTMF systems (e.g., Veeva Vault TMF or equivalent), including system governance and optimization
• Experience managing CROs/vendors and holding them accountable for TMF quality and delivery
• Education: Bachelor's degree in Life Sciences, Health Sciences, or related field required; Advanced degree preferred

Responsibilities:

• Inspection readiness expertise: Proven experience leading or supporting regulatory inspections (FDA, EMA) and audit responses
• Leadership & influence: Ability to drive alignment across senior stakeholders and embed a culture of continuous inspection readiness
• Risk-based quality management: Ability to identify TMF risks, implement mitigation plans, and monitor via KPIs/KRIs
• Strategic TMF oversight: Defines TMF strategy, governance, and standards across programs or portfolio
• Vendor oversight: Strong experience overseeing CROs and external partners to ensure TMF compliance and performance

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.