Sr. Clinical Trial Manager

Sr. Clinical Trial Manager

This role sits at the heart of global clinical development, driving the execution of complex Phase I–III clinical trials that advance innovative oncology therapies. You will oversee end-to-end study delivery across multiple regions, ensuring timelines, quality, and regulatory compliance are consistently met. Working within a highly collaborative, cross-functional environment, you will partner closely with CROs, vendors, and internal stakeholders to translate strategy into operational excellence. The position offers strong visibility and impact, directly contributing to the development of transformative radiopharmaceutical treatments for patients with cancer. It combines strategic oversight with hands-on operational leadership in a fast-paced biotech environment. You will play a key role in risk management, study performance optimization, and continuous improvement across clinical programs.

• Lead the planning, execution, and closeout of Phase I–III clinical trials, ensuring delivery against timelines, budget, and quality expectations.
• Oversee and manage CROs and vendors, ensuring compliance with SOPs, GCP/ICH guidelines, and applicable regulatory requirements from agencies such as the FDA.
• Drive cross-functional collaboration across clinical operations, data, regulatory, and medical teams to ensure study alignment and execution.
• Monitor study performance indicators including enrollment, site activation, data quality, and operational risks, escalating issues proactively when needed.
• Manage study budgets, contracts, and invoicing activities in collaboration with external partners.
• Support feasibility, site selection, and activation strategies to ensure optimal study execution.
• Summarize vendor and site performance and contribute to operational strategy and continuous improvement initiatives.

Requirements

• 5–7+ years of clinical operations experience in biotech, pharmaceutical, or CRO environments.
• Bachelor's degree in a scientific or healthcare-related discipline preferred.
• Strong understanding of clinical trial lifecycle management, including study start-up, execution, and closeout.
• Solid knowledge of Good Clinical Practice (GCP) and ICH guidelines established by the International Council for Harmonisation.
• Experience managing CROs, vendors, and cross-functional clinical study teams.
• Strong organizational, communication, and problem-solving skills with a proactive and detail-oriented mindset.
• Ability to thrive in dynamic, fast-changing environments with competing priorities.
• Proficiency with tools such as Microsoft Project and Smartsheet is preferred.

Benefits

• Competitive annual compensation range: $149,860 – $181,595 (U.S. remote role), with potential additional bonus and equity eligibility.
• Comprehensive health coverage including medical, dental, vision, and pharmacy benefits.
• Financial protection programs including 401(k), disability insurance, life insurance, legal support, and identity theft protection.
• Flexible work-life balance offerings including paid time off, holidays, and potential unlimited or enhanced leave programs depending on eligibility.
• Wellbeing resources such as employee assistance programs and wellness accounts.
• Additional support for travel protection, caregiving needs, and personal leave options.