Responsibilities:
- Drive global study start-up and site activation activities, including milestone oversight and CRO delivery.
- Develop and deliver the global study start-up plan with the CRO study start-up team.
- Lead procedures/process improvements to enhance internal start-up capabilities and efficiencies.
- Guide study teams through timely startup activities to enable predictable R&D delivery.
- Analyze clinical trial data to produce accurate study startup forecasts; benchmark assumptions/scenarios with feasibility experts.
- Develop processes/methodologies/data/technologies to sustain high-value study startup services.
- Participate in early, global strategic study planning; secure CRO commitment to deliverables and timelines.
- Partner with CROs to ensure efficient start-up processes, reporting, and best-in-practice country/site activations.
- Collaborate with internal teams and CROs to resolve site-level issues and remove roadblocks.
- Track/report KPIs and site/country cycle times to improve processes.
- Ensure consistent application of study start-up standards aligned to local operational, legal, and regulatory requirements.
- Build/maintain country and site activation best practices; support and develop junior staff.
Qualifications:
- Bachelorβs degree in science or related field (advanced degree desirable).
- 8+ years experience with a CRO or biopharmaceutical company on multinational clinical studies.
- 5+ years managing operational aspects of clinical studies.
- Required: leading global study start-up and site activation.
- Required: experience working with external CROs and cross-functional teams.
- Broad clinical development experience (trial conduct, study start-up/feasibility, country/site selection, patient recruitment/retention).
- Knowledge of GCP and clinical operations/study management/monitoring; understanding of local regulatory requirements.
U.S. Pay Range:
- $140,300.00 - $189,900.00 plus eligibility for annual short-term incentive and annual long-term incentive.
Benefits (explicitly stated):
- Medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, two recharge breaks, and family resources/leave.