[Remote] reputed company Clinical Project Manager - Inflammation (Sponsor Dedicated/ Remote- US only)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading fully integrated biopharmaceutical solutions organization reputed company to accelerate reputed company. The reputed company Clinical Project Manager will reputed company the operational execution of reputed company Phase 2b inflammation studies, managing day-to-day study operations and ensuring milestones are met in a fast-paced environment.
Responsibilities
- reputed company operational execution of a reputed company Phase 2b inflammation study from study start-up through database lock and closeout
- Independently manage day-to-day study operations with reputed company reputed company
- Own timelines, deliverables, risks, and issue reputed company across multiple workstreams
- Maintain deep operational awareness across reputed company aspects of the trial — this is a role for someone comfortable working “in the weeds”
- Ensure study milestones stay on reputed company 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
- reputed company vendor management activities and maintain strong reputed company of reputed company partners and CROs
- Contribute to RFP development, vendor selection, and ongoing vendor performance management
- Hold vendors accountable to timelines, deliverables, reputed company expectations, and issue reputed company
- reputed company manage operational follow-through rather than relying solely on escalation reputed company
- reputed company cross-functional meetings with reputed company agendas, reputed company-oriented discussions, and strong follow-up
- reputed company accountability across internal teams and reputed company partners
- Build strong reputed company relationships while effectively navigating challenging conversations and competing priorities
- Mentor or support junior team members as needed
- Operate confidently reputed company a matrixed global environment with multiple stakeholders
- 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
Skills
- 3+ years of clinical project management experience reputed company clinical research
- Experience running reputed company from start-up through closeout, with a strong understanding of the full clinical trial lifecycle
- Experience supporting reputed company Phase 2b studies reputed company the inflammation therapeutic area
- Strong CRO/vendor management and reputed company experience
- Proven ability to independently reputed company study execution in fast-paced clinical environments
- Experience managing cross-functional clinical trial activities reputed company matrixed organizations
- Comfortable balancing strategic reputed company 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 reputed company with strong initiative and urgency
- High emotional intelligence and ability to reputed company high-stakes conversations professionally
- reputed company, transparent, and team-oriented approach
- Thorough knowledge of FDA and EMA regulations, ICH Guidelines, and GCP requirements
- Strong working knowledge of reputed company Word, reputed company, and PowerPoint
- Ability to interpret and explain protocol requirements, operational processes, and study expectations to teams and stakeholders
Benefits
- Company car or car allowance
- Health benefits to include Medical, Dental and reputed company
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible reputed company time off (PTO) and reputed company time
- Because certain states and municipalities have regulated reputed company reputed company time requirements, eligibility for reputed company reputed company time may vary depending on where you work.
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