Key Responsibilities
- Support the planning, setup, and execution of global clinical trials, ensuring delivery according to timelines, quality standards, and regulatory requirements.
- Maintain accurate documentation and participate in inspection readiness activities for trial oversight.
- Collaborate with CROs and internal stakeholders for site feasibility, selection, activation, and ongoing site management.
- Oversee service providers by tracking deliverables, timelines, and quality.
- Support risk identification and mitigation and contribute to risk-based quality management throughout the trial lifecycle.
- Manage protocol deviations and trial-level issues with proper documentation, follow-up, and escalation.
- Support trial data review and performance tracking to report and identify potential issues.
- Work collaboratively in a global, matrixed environment, building strong relationships with internal teams, vendors, and investigators.
Qualifications
- Bachelor’s degree in life sciences or related field (Master’s preferred).
- 5+ years of clinical trial management experience in pharma/biotech.
- Solid understanding of ICH/GCP regulations and the clinical drug development lifecycle.
- Experience managing global, multi-center trials in a complex, matrixed organization.
- Project management and service provider oversight skills.
- Strong communication, collaboration, and interpersonal skills.
- Oncology and/or therapeutic area–specific experience highly desirable.
Benefits (US)
- 401(k) 100% match on first 6% (within first year).
- Health, dental, and vision; voluntary plans (critical illness, accident, hospital indemnity).
- Paid vacation, sick leave, holidays, and 12 weeks discretionary paid parental leave.
- Child/adult backup care, family support programs, financial wellness tools, emotional well-being support.
- Commuter benefits, tuition reimbursement, Lifestyle Spending Account.