Key Responsibilities:
- Lead operational planning, setup, and execution of global clinical trials, ensuring on-time delivery and compliance with regulatory and quality standards.
- Oversee trial documentation and systems to ensure accuracy, completeness, and inspection readiness.
- Drive site feasibility, selection, and activation strategies with CROs and internal stakeholders.
- Manage CROs and other service providers to ensure high-quality deliverables, timeline adherence, and effective collaboration.
- Identify, assess, and mitigate operational risks using risk-based quality management approaches.
- Oversee protocol deviations and issue management; ensure appropriate escalation and resolution of trial-level challenges.
- Monitor trial performance and data quality using key metrics to drive decision-making and continuous improvement.
- Serve as a key cross-functional leader, fostering collaboration across internal teams, vendors, and investigators.
Qualifications:
- Bachelorβs degree in life sciences or related field (Masterβs preferred).
- 8+ years of clinical trial management experience in pharma/biotech.
- Solid knowledge of ICH/GCP regulations and the clinical drug development lifecycle.
- Proven experience managing global, multi-center trials in a complex, matrixed organization.
- Strong project management and service provider oversight skills.
- Excellent communication, collaboration, and interpersonal skills.
- Oncology and/or therapeutic area experience highly desirable.
- Ability to lead without authority and mentor others in a cross-functional environment.
What We Offer (U.S. employees, first year):
- 401(k) with 100% match on first 6% of contributions; health (2 medical options including HDHP/HSA), dental, vision.
- Voluntary plans: critical illness, accident, hospital indemnity.
- Paid vacation/sick leave/holidays; 12 weeks discretionary paid parental leave.
- Backup care, family support, financial wellness tools, emotional well-being support.
- Commuter benefits, tuition reimbursement, Lifestyle Spending Account.
- Proposed salary band (U.S.): $130,720β$196,080; additional compensation may apply.