Experienced Clinical Project Manager – Inflammation

This is a fully remote position, open to applicants in Arizona, +3 more states.

📋 Description

• Oversee the operational execution of a complex Phase 2b inflammation study from the initiation phase through database lock and closeout.

• Independently handle daily study operations with minimal supervision.

• Take ownership of timelines, deliverables, risks, and issue resolution across various workstreams.

• Maintain operational awareness of all trial components to ensure milestones are met.

• Collaborate cross-functionally to identify risks, eliminate obstacles, and implement operational solutions.

• Lead vendor management, oversee CRO operations, develop RFPs, select vendors, and manage vendor performance.

• Hold vendors accountable for timelines, deliverables, quality standards, and issue resolution.

• Facilitate cross-functional meetings and promote accountability within internal teams and external partners.

• Cultivate collaborative relationships, navigate difficult conversations, and mentor or support junior team members.

• Draft, review, and coordinate documents such as protocols, informed consents, monitoring plans, investigator brochures, and clinical study reports.

• Assist in tracking study budgets, forecasting, and operational planning.

• Review data listings and support both interim and final reporting activities.

• Provide training to CROs, investigators, study coordinators, and vendors on protocol and study requirements.

• Contribute to the development of SOPs, process improvement initiatives, and operational best practices.

⛳️ Requirements

• Minimum of 3 years of clinical project management experience in clinical research.

• Proven experience in managing clinical trials from initiation to closeout.

• Strong grasp of the entire clinical trial lifecycle.

• Experience with complex Phase 2b studies in the inflammation therapeutic area.

• Robust CRO/vendor management and oversight experience.

• Demonstrated ability to independently drive study execution in dynamic clinical environments.

• Experience managing cross-functional clinical trial activities within matrixed organizations.

• Capability to balance strategic oversight with practical operational execution.

• Highly organized with excellent follow-through and attention to operational details.

• Ability to prioritize tasks effectively and adapt quickly in fast-paced settings.

• Strong skills in meeting leadership, communication, and stakeholder management.

• Capacity to promote accountability across teams and vendors.

• Solutions-focused mindset with a strong sense of initiative and urgency.

• High emotional intelligence and the ability to handle high-stakes conversations professionally.

• In-depth knowledge of FDA and EMA regulations, ICH Guidelines, and GCP requirements.

• Proficient in Microsoft Word, Excel, and PowerPoint.

• Ability to interpret and explain protocol requirements, operational processes, and study expectations.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a total rewards program.

• Company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunities to earn commissions or bonuses based on individual and company performance.

• Flexible paid time off (PTO).

• Sick leave.

• Reasonable accommodations when appropriate.