Job Responsibilities

Position Summary

We are seeking an experienced Clinical Project Manager, Early Phase Clinical Research to lead and oversee Phase I and early development clinical trials from study start-up through closeout. The successful candidate will serve as the primary point of contact for sponsors and internal stakeholders, ensuring studies are delivered on time, within budget, and in compliance with Good Clinical Practice (GCP), ICH guidelines, company SOPs, and regulatory requirements.

This role requires strong project leadership, sponsor-facing experience, and a deep understanding of the unique operational challenges associated with early-phase clinical studies, including First-in-Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), proof-of-concept, Clinical Pharmacology and other exploratory clinical trials.

Key Responsibilities

Project Leadership & Study Delivery

• Lead all aspects of assigned early-phase clinical trials from study startup through database lock and closeout.
• Serve as the primary liaison between sponsors, internal teams, vendors, and study sites.
• Develop and manage project timelines, milestones, resources, risks, finances, and deliverables.
• Ensure projects are executed according to contractual commitments, study protocols, and operational plans.
• Lead cross-functional project teams to achieve study goals while maintaining quality, timelines, and budget expectations.
• Coordinate activities and deliverables across internal departments and external partners.

Financial & Operational Oversight

• Maintain accountability for overall project financial performance, including budget management, forecasting, and change order identification.
• Monitor project scope and proactively manage risks, issues, and resource requirements.
• Develop contingency plans and risk mitigation strategies to ensure successful study execution.
• Provide regular project status updates and reports to clients and senior leadership.

Quality & Regulatory Compliance

• Ensure studies are conducted in compliance with GCP, ICH guidelines, company SOPs, and applicable regulatory requirements.
• Maintain oversight of Trial Master File (TMF) quality, completeness, and inspection readiness.
• Ensure accurate maintenance of study information within CTMS and other clinical systems.
• Support audit and inspection readiness activities throughout the study lifecycle.
• Maintain accountability for project documentation and all assigned study deliverables.

Client & Stakeholder Management

• Build strong relationships with sponsors through consistent communication and successful project delivery.
• Lead internal and external project meetings, including governance and study team meetings.
• Present project updates, risks, mitigation plans, and key milestones to clients and executive stakeholders.
• Participate in bid defense meetings and support business development initiatives as needed.
• Identify opportunities for future business and expanded client partnerships.

Team Leadership

• Provide leadership and direction to cross-functional study teams.
• Foster collaboration and accountability across operational functions.
• Mentor junior team members and clinical operations staff as appropriate.
• May provide line management responsibilities for project management and clinical monitoring personnel.

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related scientific discipline; or an equivalent combination of education and experience.
• Minimum of 5+ years of clinical research experience with progressive project management responsibilities.
• Experience managing Phase I and/or early-phase clinical trials.
• Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.
• Demonstrated ability to manage multiple projects in a fast-paced clinical research environment.
• Strong financial management and budget oversight experience.
• Exceptional organizational, problem-solving, and risk management skills.
• Excellent verbal and written communication, presentation, and stakeholder management skills.
• Ability to work independently while effectively leading cross-functional teams.
• Proficiency with CTMS, eTMF, and related clinical trial technologies.
• Willingness to travel approximately 25%.

Preferred Qualifications

• Experience within a Contract Research Organization (CRO).
• Direct experience supporting First-in-Human (FIH), SAD, MAD, clinical pharmacology (i.e. DDI, TQT, FE, BA/BE), or proof-of-concept studies.
• Experience managing studies involving healthy volunteers, specialty and/or patient populations.
• Vendor management and oversight experience.
• Previous people leadership or line management experience.
• Experience with decentralized and technology-enabled clinical trials.

What Success Looks Like

• Delivering studies on time, within budget, and with high quality.
• Building trusted partnerships with sponsors and investigative sites.
• Maintaining audit and inspection readiness.
• Proactively identifying and mitigating study risks.
• Successfully leading cross-functional teams through the complexities of early clinical development.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.