Project Manager II – Investigator Research; ISR and Collaborative; CO studies; Spon

Project Manager II – Investigator Sponsored Research (ISR) and Collaborative (CO) studies (Sponsor Dedicated/Remote)

Updated: January 12, 2026

Location: Morrisville, NC, United States

Job : -OTHLOC-1500-2

DIA-2DR

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self cultureis what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Project Manager II – Investigator Sponsored Research (ISR) and Collaborative (CO) studies. Sponsor Dedicated

Location: Remote (U.S.

-based candidates only)

We are seeking a highly capable and hands‑on Project Manager II to support Investigator Sponsored Research (ISR) and Collaborative (CO) studies for a leading biopharmaceutical sponsor, in a fully sponsor‑dedicated capacity. This is a high‑ownership role designed for an experienced clinical professional who thrives in a fast‑paced, lean environment. You will be fully embedded within the sponsor’s team and responsible for managing all aspects of study execution.

• Lead cross‑functional team meetings, vendor discussions, and site calls, ensuring timely issue resolution and seamless communication.
• Independently develop and manage study timelines, project trackers, and operational deliverables.
• Oversee site and vendor selection, budget planning, and resource tracking to ensure trials are executed within scope and on time.
• Ensure adherence to GCP, SOPs, and country‑specific regulations, while maintaining consistency across studies.
• Monitor trial performance, drive risk identification and mitigation, and support resolution of operational and quality issues.
• Collaborate cross‑functionally with teams including regulatory affairs, clinical development, data management, and safety.
• Contribute to inspection readiness, including TMF oversight, compliance tracking, and CAPA support.

• Previous experience managing ISR/CO studies.
• 5+ years of clinical research experience, with 2+ years in clinical project management or study leadership roles.
• Proven success operating in a lean, high‑accountability environment with limited Clinical Operations support.
• Strong knowledge of clinical trial lifecycle, from startup to closeout, including vendor oversight and budget management.
• Expertise in GCP, ICH guidelines, and applicable regulatory requirements for early‑phase trials.
• Experience working within a CRO setting in a sponsor‑facing capacity is strongly preferred.
• Proficient in clinical systems (e.g., CTMS, eTMF, EDC) and project management tools.
• Bachelor’s degree in Life Sciences, Clinical Research, or a related field. Advanced degrees or certifications (PMP, CCRA, CCRP) are a plus.

• Lead with…