Sr Clinical Project Manager - Early Phase

Syneos Health, Inc.; United States; Remote; USD 130,000 - 180,000; Full time

Job summary

Syneos Health, Inc. is seeking an experienced Senior Clinical Project Manager for Early Phase to lead Phase I trials from start-up through closeout. You will serve as the key contact for sponsors and internal stakeholders, ensuring studies run on time, within budget, and compliant with GCP/ICH and SOPs.

You will navigate early-phase operational challenges, collaborate with cross-functional teams, and drive study delivery while maintaining high quality and regulatory readiness.

Qualifications

• Experience leading early-phase clinical trials (Phase I) from start-up to closeout.
• Strong sponsor-facing and stakeholder management skills.
• Proven ability to manage timelines, budgets, and study deliverables.

Responsibilities

• Lead all aspects of assigned early-phase trials from startup to closeout.
• Serve as primary liaison between sponsors, internal teams, vendors and sites.
• Develop and manage timelines, milestones, resources, risks, finances and deliverables.

Skills

Clinical PM

Early phase

Sponsor liaison

Cross-functional leadership

Education

Bachelor's degree in life sciences

Tools

CTMS

EDC systems

Job description

Sr Clinical Project Manager - Early Phase

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

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