Senior Clinical Trial Manager

Responsibilities:

• Execute clinical operations strategy for high-touch, patient-centered clinical trials, with a focus on adaptive and seamless designs to support registration.
• Ensure trial deliverables are met on timelines, budget, operational procedures, and quality standards (may include contributing to study documents, developing study tools/guidelines/training, managing clinical study materials, and implementing issue resolution plans).
• Manage relationships and work efficiently with external collaboration partners.
• Proactively identify, assess, and manage clinical study challenges and risks.
• Support oversight of study activities including site identification/selection, enrollment models, clinical supply planning, budget planning, and trial execution.
• Monitor CRO/third-party vendor performance and compliance with applicable regulations/guidelines through regular contact (e.g., CRAs).
• Develop and/or revise CRO scope of service agreements, budgets, plans, and detailed timelines to ensure performance expectations are met.
• Participate in development/authorship of study documents (e.g., protocol, investigator brochure, informed consent).
• Participate in Case Report Form design, user acceptance testing with Data Management, and data monitoring.
• Oversee study management and/or clinical development teams (CROs) to meet clinical development goals and study quality metrics.
• Execute CRO/third-party oversight (e.g., monitoring report review, periodic data quality review, CRO/vendor KPI review, sponsor oversight visits).
• Contribute to and/or author clinical sections of regulatory documents (e.g., Investigator’s Brochures, safety updates, responses to Health Authority/Ethics Committee questions).
• May manage a team of Clinical Trial Associates (hiring, career/professional development).

• Bachelor’s degree required (preferably Life Sciences: Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• 5+ years clinical trial management experience in pharma/biotech/CRO.
• Ability to manage global clinical trials across regions (regulatory, cultural, and site capability differences).
• Phase 2/Phase 3 experience strongly preferred.
• Oncology study experience strongly preferred.
• Clinical research operational knowledge; computer literacy; strong project planning/management with CRO/vendor oversight.
• Global clinical trial management in fast-paced CRO outsourced environment.
• Experience managing global/regional teams in a virtual environment.
• Strong decision-making and communication/collaboration; analytic problem-solving.
• Adaptable; thrives in fast-paced environment.
• Effective leadership; ability to foster productivity, cohesiveness, and quality deliverables.
• Travel 10–20% of the time.

• Compensation range: $176K–$197K.