Clinical Study Manager

About the role

This position will oversee assigned clinical research projects, protocol development, site management, monitoring, TMF management, cross-departmental collaboration and communication, and documenting and tracking execution of projects to adhere to milestones, budgets, and targeted timelines.

Essential Duties and Responsibilities

• Manage end-to-end lifecycle of assigned IVD clinical research projects, including startup, site management, monitoring, and closeout.
• Cook up IRB submissions, laboratory shipments and incoming samples, sample receipt logging, kit creation and inventory, and ensure study deliverables are achieved on time and within budget.
• Oversee TMF, CTMS, and database for assigned projects. Participate in development of protocols, ICFs, CRFs, and other study-related documents.
• Build study budgets and timelines, establish milestones, and coordinate site selection and activation. Track metrics and summarize clinical data for project updates, reports and publications.
• Serve as the primary liaison between the sponsor, vendor, sites, and internal cross-functional teams for assigned projects.
• Ensure project compliance with ICH-GCP guidelines, IRB requirements, FDA regulations, and any other applicable requirements.
• Contribute to the forecasting and management of resources. Identify future potential studies to address unmet needs.
• Support the onboarding of new technologies, progression of scientific innovation projects, and process improvement initiatives.
• Perform all other duties as assigned.

Qualifications/Requirements

• Bachelor's degree in a health or science field required.
• At least 5 years of experience in clinical research, with specific experience in studies used for FDA/regulatory submission required. Direct trial management experience and prior experience working at the sponsor/CRO level required.
• Experience in IVD or medical device clinical research strongly preferred.
• Clinical research certification (e.g. ACRP, SOCRA) strongly preferred.
• Knowledge of Good Clinical Practice (GCP)/ICH and medical device clinical trial guidelines, rules, and regulations. Understanding of Good Laboratory Practice (GLP), research safety, HIPAA, confidentiality, and regulatory standards & requirements.
• Strong organizational skills and attention to detail. Ability to work autonomously and strong decision-making skills.
• Excellent written and verbal communication skills.
• Ability to travel overnight and out-of-state occasionally (20%).

Physical Requirements/Working Conditions/Equipment Used

• Office reachable by elevator but should be able to climb stairs if needed
• Light lifting may be required (up to 25 pounds)
• Ability to work in an environment with exposure to hazardous chemicals and biohazards
• Ability to operate a computer throughout course of day
• General office and HVAC noise & fluorescent and/or LED lighting

Benefits

Cleveland Diagnostics offers an extremely robust benefits package which includes:

• 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
• 100% Employer-paid Dental & Vision for entire family
• No cost for employee coverage for Basic Group Term Life, Short- & Long-Term Disability
• 4% retirement contribution Employer match
• Promotion/Performance Pay, Incentive Performance Plan & Stock Option Program & Commissions (Sales Account Execs)
• Paid Family Leave Program and the rest of the alphabet soup: EAP, FSAs, HSA & more!
• Generous PTO plan & holiday program
• Flexible work schedule & lucrative employee referral program
• Salary range may vary by work state, depth of education & experience, geographical region/territory

Pay Range

$90,000 - $120,000 per year

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