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)

Syneos Health is a leading biopharmaceutical solutions organization focused on accelerating customer success. This role is based remotely in the U.S.

Remote (U.S.

-based candidates only)

• 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 the 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 (CTMS, eTMF, EDC) and project management tools.
• Bachelor’s degree in Life Sciences, Clinical Research, or related field. Advanced degrees or certifications (PMP, CCRA, CCRP) are a plus.

• Lead with autonomy:
  Manage early‑phase studies independently, driving execution in a critical development space.
• Be sponsor‑facing, stay CRO‑supported:
  Enjoy full sponsor integration while maintaining CRO resources, tools, and career support.
• Remote flexibility:
  Work from anywhere in the U.S. while collaborating with global teams.
• Grow intentionally:
  Clear opportunities for advancement into senior project leadership roles.

• Company car or car allowance.
• Health benefits – Medical, Dental, Vision.
• Company match 401(k).
• Eligibility to participate in Employee Stock Purchase Plan.
• Commissions/bonus based on performance.
• Flexible paid time off (PTO) and sick time.

Syneos Health 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. The company affirms its commitment to equal opportunity and diversity.