Project Manager II - Inflammation/Phase 2b; Sponsor-Dedicated/Remote -U.S
Warwick, Kent County, Rhode Island, 02888, USA
Listed on 2026-06-03
-
Business
Operations Manager
Project Manager II – Inflammation/Phase 2b (Sponsor Dedicated – Remote; Preference for Hybrid Foster City, CA)
Responsible for leading end‑to‑end operational execution of a complex Phase 2b inflammation study from start‑up through database lock and closeout.
Job Responsibilities- Drive operational execution of the study from start‑up through database lock and closeout.
- Manage day‑to‑day study operations with minimal oversight.
- Own timelines, deliverables, risks, and issue resolution across multiple work streams.
- Maintain deep operational awareness and keep study milestones on track in a fast‑paced environment.
- Partner cross‑functionally to proactively identify risks, remove roadblocks, and implement operational solutions quickly.
- Lead vendor and CRO management activities, maintain strong oversight of external partners and CROs.
- Contribute to RFP development, vendor selection, and ongoing vendor performance management.
- Hold vendors accountable to timelines, deliverables, quality expectations, and issue resolution.
- Lead cross‑functional meetings with clear agendas, action‑oriented discussions, and strong follow‑up.
- Build and maintain strong collaborative relationships while navigating challenging conversations.
- Mentor or support junior team members as needed.
- Draft, review, and coordinate key study documents such as protocols, informed consents, monitoring plans, investigator brochures, and clinical study reports.
- Support study budget tracking, forecasting, and operational planning activities.
- Review data listings and support interim/final reporting activities.
- Train CROs, investigators, study coordinators, and vendors on protocol and study requirements.
- Contribute to SOP development, process improvement initiatives, and operational best practices.
- 3+ years of clinical project management experience within clinical research.
- Experience running clinical trials from start‑up through closeout.
- Experience supporting complex Phase 2b studies within the inflammation therapeutic area.
- Strong CRO/vendor management and oversight experience.
- Proven ability to independently drive study execution in fast‑paced clinical environments.
- Experience managing cross‑functional clinical trial activities within matrixed organizations.
- Comfortable balancing strategic oversight with hands‑on operational execution.
- Highly organized with exceptional follow‑through and attention to operational detail.
- Comfortable working in the weeds while maintaining a high‑level program perspective.
- Ability to prioritize effectively and pivot quickly in fast‑moving environments.
- Strong meeting leadership, communication, and stakeholder management skills.
- Confident driving accountability across teams and vendors.
- Solutions‑oriented mindset with strong initiative and urgency.
- High emotional intelligence and ability to navigate high‑stakes conversations professionally.
- Collaborative, transparent, and team‑oriented approach.
- Thorough knowledge of FDA and EMA regulations, ICH Guidelines, and GCP requirements.
- Strong working knowledge of Microsoft Word, Excel, and PowerPoint.
- Ability to interpret and explain protocol requirements, operational processes, and study expectations to teams and stakeholders.
- Competitive salary range: $95,000.00 – $.
- Potential company car or car allowance.
- Health benefits (Medical, Dental, Vision).
- Company match 401(k).
- Eligibility to participate in Employee Stock Purchase Plan.
- Eligibility to earn commissions/bonus based on company and individual performance.
- Flexible paid time off (PTO) and sick time (eligibility may vary by state/municipality).
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.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).