Director, Respiratory Clinical Operations

🕒 April 14

🧀 Wisconsin – Remote

🧀 Wisconsin – Remote

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

👻 Ghost score 65%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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MERIT CRO

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2012

🏥 Healthcare

💊 Pharmaceuticals

☁️ SaaS

💰 $1.1M Venture Round - MERIT on 2023-07

Healthcare • Pharmaceuticals • SaaS

MERIT CRO is an innovative clinical endpoint expert and contract research organization that partners with CROs, pharmaceutical and biotech sponsors to provide centralized endpoint services for global clinical trials. It focuses on therapeutic areas including ophthalmology, oncology, respiratory and cardiology and offers specialized services such as reading center services, BCVA certification, centralized image storage, endpoint assessments, and clinical operations support. MERIT also provides a cloud-based software platform (EXCELSIOR) for real-time, single-system access to trial endpoints and emphasizes quality and compliance evidenced by ISO 13485 and ISO 27001 certifications and FDA 510(k) clearance. The company positions itself as a B2B service provider aimed at improving the reliability and efficiency of imaging- and endpoint-driven clinical trials.

📋 Description

• Lead and oversee all respiratory clinical operations across multiple concurrent studies • Ensure delivery on time, on budget, and in compliance with applicable regulations, SOPs, and ICH-GCP guidelines • Serve as an internal subject matter expert in respiratory disease and clinical-trial spirometry and HRCT • Manage, mentor, and develop Project Managers, Respiratory Therapists, contractors, and consultants • Monitor workload and coverage while fostering accountability, growth, and high performance • Serve as the primary point of contact for sponsors and vendors • Communicate project status, proactively escalate issues, and represent MERIT in client presentations, bid defenses, and operational discussions • Drive process improvement and department-building initiatives, including SOPs, training programs, and scalable operational frameworks • Oversee centralized data review processes and contractor relationships • Ensure quality control of respiratory and imaging data and timely resolution of discrepancies with data management and cross-functional teams • Maintain rigorous documentation and communication standards • Provide status updates to senior leadership and ensure project activity is tracked, reported, and audit-ready • Perform other duties as assigned

🎯 Requirements

• Bachelor's degree in a scientific or health-related field required • Master's degree preferred • PMP certification is a plus • Minimum of 10 years of clinical research experience, with significant focus in respiratory clinical trials • Expert knowledge of respiratory diseases, including IPF, interstitial diseases, COPD, and asthma • Direct experience with spirometry and HRCT in a clinical trial context • Minimum of 5 years of experience managing clinical trials as a Project Manager or in a comparable role at a pharmaceutical/biotech company or CRO • Minimum of 2 years of supervisory experience with a demonstrated track record of developing and retaining talent • Experience managing central reviews and third-party contractors/vendors • Experience supporting business development activities including client presentations and bid defenses • Exceptional written and verbal communication skills • Proven ability to prioritize and manage multiple competing demands in a fast-paced, evolving environment • Proficiency in Microsoft Office; ability to learn company-specific software • Ability and willingness to travel up to 10%

🏖️ Benefits

• 401k retirement plan • 8 Paid Holidays • Healthcare Insurance • Paid Life and AD&D Insurance • Paid Long-Term Disability • Paid Time Off (vacation & sick) • Work life balance