Lead the strategic planning and execution of study start-up activities across clinical programs, ensuring rapid, high-quality site activation.
Provide leadership to cross-functional teams, oversee budgets, engage key stakeholders, and drive continuous process improvements.
Develop and implement activation strategies, manage regulatory and ethics submissions (IRB/EC and Health Authorities), oversee site contract and budget negotiations.
Monitor operational KPIs, ensure audit and inspection readiness, and lead end-to-end study start-up activities.
Drive continuous improvement initiatives focused on reducing activation timelines and increasing predictability, and evaluate and introduce innovative tools.
Champion change management related to new systems, SOPs, and operational models.

Requirements

Bachelor’s degree in a life sciences discipline required; advanced degree preferred.
At least 12 years of clinical research experience, with 6 years in clinical operations leadership roles in sponsor/biotech/CRO settings.
Proven track record of operational excellence in delivering clinical trials, ideally including innovative approaches to speed up study start-up and site activation.
Extensive experience as a direct line manager with responsibility for performance management and team development.
Expert knowledge of global clinical trial regulations (ICH-GCP, FDA, local regional authorities).
Strong expertise in global study start-up processes—including clinical trial package preparation, submissions, contracting, and site activation.
Advanced risk management and problem-solving abilities.
Strong financial acumen including budget forecasting and cost oversight.
Ability to work independently and manage multiple priorities effectively.

Benefits

Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Annual bonus plan
Incentive compensation plan
Employee Stock Purchase Plan

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical researchclinical operationsstudy start-upregulatory submissionsbudget managementKPI monitoringrisk managementproblem-solvingclinical trial regulationssite activation

Soft Skills

leadershipcross-functional team managementstakeholder engagementcontinuous improvementchange managementperformance managementteam developmentindependent workmulti-priority managementfinancial acumen