Clinical Operations Manager Jobs in Middleton, WI

Updated: Yesterday
Location: Remote, OR, United States
Job ID:25111478-OTHLOC-1500-2DOR-2DR

Description Experienced Clinical Project Manager - Inflammation (Sponsor Dedicated/ Remote- US only)

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 culture is 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.

Sponsor-Dedicated | Remote (U.S. only)

Are you a clinical project management professional who knows how to take ownership of a study from start-up through closeout — not just oversee it from a distance, but truly drive execution day-to-day?

This is a highly visible opportunity supporting a complex Phase 2b inflammation program within a fast-paced sponsor-dedicated environment where strong operational leadership, accountability, and execution matter. The ideal candidate is comfortable operating both strategically and tactically — someone who can lead cross-functional teams while also rolling up their sleeves and working in the details to keep a study moving forward.

If you thrive in high-accountability environments, can navigate ambiguity, and enjoy being deeply involved in clinical trial execution from start to finish, this role offers the opportunity to make a direct impact.

• High-impact role supporting a complex Phase 2b inflammation study
• Opportunity to lead regional execution efforts within a large global clinical program
• Strong visibility across Clinical Operations, leadership, and external partners
• Fast-moving environment where decisions and execution happen quickly
• Significant ownership and autonomy with the expectation to independently drive study progress
• Collaborative sponsor-dedicated culture with supportive leadership and strong team partnership
• Opportunity to work alongside highly experienced clinical operations professionals in a hands‑on environment

End-to-End Clinical Trial Execution

• Drive operational execution of a complex Phase 2b inflammation study from study start-up through database lock and closeout
• Independently manage day-to-day study operations with minimal oversight
• Own timelines, deliverables, risks, and issue resolution across multiple workstreams
• Maintain deep operational awareness across all aspects of the trial — this is a role for someone comfortable working “in the weeds”
• Ensure study milestones stay on track in a fast-paced environment with shifting priorities and competing demands
• Partner cross-functionally to proactively identify risks, remove roadblocks, and implement operational solutions quickly

Vendor & CRO Oversight

• Lead vendor management activities and 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
• Actively manage operational follow-through rather than relying solely on escalation pathways

Cross-Functional Leadership

• Lead cross-functional meetings with clear agendas, action-oriented discussions, and strong follow-up
• Drive accountability across internal teams and external partners
• Build strong collaborative relationships while effectively navigating challenging conversations and competing priorities
• Mentor or support junior team members as needed
• Operate confidently within a matrixed global environment with multiple stakeholders

Study Operations & Documentation

• Draft, review, and coordinate key study documents including 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, with a strong understanding of the full clinical trial lifecycle
• 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 still 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

This team values collaboration, accountability, and execution. The environment is fast-paced, highly interactive, and best suited for individuals who enjoy being actively engaged in study operations rather than operating at a distance