Remote Associate Director, TMF & Clinical Operations

Piper Companies; United States; Remote; USD 130,000 - 155,000; Full time

Job summary

Piper Companies seeks an Associate Director, Clinical Operations - TMF to lead TMF strategy, governance, and operational execution across multiple trials, ensuring inspection readiness. This remote role requires strong oversight of TMF quality and regulatory compliance in CRO/pharma settings.

Experience with Veeva Vault TMF is highly preferred. The position emphasizes leadership, cross-functional collaboration, and strategic PROPOSAL/forecasting work, with a focus on improving TMF processes and

Qualifications

• 10+ years in pharmaceutical/biotech/CRO environments with increasing leadership responsibilities.
• 6+ years owning TMF strategy and managing TMF operations and teams.
• Expert knowledge of ICH-GCP, FDA regulations, and TMF references.
• Hands-on experience developing TMF plans, SOPs, and governance docs.
• Experience supporting regulatory inspections and sponsor audits.
• Proven ability to work across functions and manage proposals and budgets.

Responsibilities

• Lead TMF strategy, governance, and execution across multiple trials with inspection readiness.
• Oversee TMF quality, completeness, accuracy, and timeliness per ICH-GCP and FDA regs.
• Develop and maintain TMF plans, filing structures, and SOPs.
• Provide leadership to Clinical Operations Managers and TMF staff.
• Serve as TMF SME for sponsors, audits, and regulatory interactions.
• Drive process improvements, risk mitigation, and TMF health metrics.
• Support proposal development, resource forecasting, and budget planning.

Skills

Leadership

Project management

Communication

Resource planning

Regulatory compliance

Proposal development

Governance

Strategic thinking

Education

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Tools

Veeva Vault TMF

eTMF systems

Job description

Piper Companies seeks an Associate Director, Clinical Operations - TMF to lead TMF strategy, governance, and operational execution across multiple trials, ensuring inspection readiness. This remote role requires strong oversight of TMF quality and regulatory compliance in CRO/pharma settings.

Experience with Veeva Vault TMF is highly preferred. The position emphasizes leadership, cross-functional collaboration, and strategic PROPOSAL/forecasting work, with a focus on improving TMF processes and