Senior Clinical Project Manager- Remote

Position Overview

We are conducting a confidential search for a Senior Clinical Project Manager for a well-funded biotech expanding its U.S. medical organization. Backed by strong investors and over $1 billion in global partnering value, the company offers a fast-paced, autonomous, and innovation-driven environment.

Reporting directly to the Operations Director, this individual will be responsible for the operational management and execution of assigned clinical trials from study initiation through close-out. The Senior Clinical Project Manager will apply strong clinical operations and project management expertise; including U.S. First-in-Human and early-phase study experience to drive study execution, regulatory compliance, patient enrollment, vendor oversight, and cross-functional alignment.

This is a hands-on sponsor-side role for an experienced Clinical Project Manager who is ready to assume broader ownership of clinical study delivery while collaborating with teams and external partners across the United States, China, and other regions.

Key Responsibilities

• Monitor study status against timelines, milestones, budgets, and deliverables, and proactively implement adjustments to keep trials on track.
• Identify, assess, and monitor trial-level risks, and develop appropriate mitigation and contingency plans with cross-functional stakeholders.
• Proactively resolve complex operational issues and escalate significant risks to Clinical Operations leadership when appropriate.
• Develop and maintain study budgets, forecasts, financial assumptions, and operational tracking tools.
• Support CRO and vendor qualification, selection, contracting, oversight, and performance management.
• Ensure that CROs, vendors, and clinical sites perform in accordance with study requirements, applicable SOPs, ICH-GCP, FDA requirements, and relevant regulations.
• Collaborate with Clinical Development, Regulatory Affairs, Medical, Quality, Legal, Supply Chain, and other functions on protocols, study plans, clinical supplies, and trial-related documentation.
• Organize and lead study team, CRO, vendor, and site meetings, and provide clear updates on study progress, risks, decisions, and action items.
• Develop and track patient enrollment plans and support the execution of recruitment strategies to achieve enrollment objectives.
• Work with internal Quality teams, CROs, and investigational sites to ensure data quality, protocol compliance, and timely issue resolution.
• Conduct or participate in quality control visits, co-monitoring visits, audits, regulatory inspections, and inspection-readiness activities as needed.
• Maintain effective working relationships with U.S. academic medical centers, community research sites, investigators, CROs, vendors, and other external partners.
• Serve as a key operational liaison among internal functional leads, clinical sites, CROs, vendors, and external stakeholders.
• Contribute to the development and continuous improvement of clinical operations processes, procedures, tools, and templates.
• Perform other responsibilities assigned by Clinical Operations leadership based on study and business needs.

Qualifications

• Bachelor’s degree in biological sciences, healthcare, life sciences, or a related field. A master’s degree or other advanced degree is preferred.
• Ten years of clinical research or clinical operations experience, including at least five years of clinical trial or project management experience.
• Exceptional candidates with slightly fewer years of experience and highly relevant clinical trial management experience may be considered.
• Demonstrated experience managing U.S. clinical trials within a biotechnology, pharmaceutical, or CRO environment.
• U.S. First-in-Human, Phase I, Phase I/II, or other early-phase clinical trial experience is strongly preferred.
• Experience in both sponsor and CRO environments, or experience transitioning from CRO study delivery into sponsor oversight, is preferred.
• Demonstrated experience with CRO and vendor oversight, study timelines, budgets, enrollment, site management, risk mitigation, and cross-functional coordination.
• Experience working with U.S. academic medical centers and community research sites.
• Experience supporting global studies or collaborating with U.S.- and China-based teams is preferred.
• Working knowledge of ICH-GCP, FDA clinical trial requirements, and sponsor/CRO operating models.
• Strong written and verbal communication skills in English.
• Professional working proficiency in Mandarin Chinese is strongly preferred due to regular collaboration with China-based teams.
• Working knowledge of Microsoft Office, Microsoft Project, or comparable project management and scheduling tools.
• Willingness to travel for clinical site visits, investigator meetings, audits, inspections, and company meetings as required.

Key Attributes

• Strong ownership and accountability
• Reliable execution and disciplined follow-through
• Early identification and communication of risks
• Strong problem-solving and time-management skills
• High attention to detail and strong organizational ability
• Credible management of CROs, vendors, investigators, and clinical sites
• Clear and concise cross-functional communication
• Results-driven and comfortable working in a hands-on environment
• Ability to collaborate effectively across U.S., China, and global team

Salary and Benefits

· Base salary of up to $145,000, depending on experience and qualifications, plus performance bonus

· Medical, Dental, Vision Coverage

· 401k with match