Clinical Research Project Manager

Cleveland Diagnostics • Cleveland, OH

2d • Onsite

About The Position

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. The role involves managing the end-to-end lifecycle of assigned IVD clinical research projects, including startup, site management, monitoring, and closeout. The Clinical Research Project Manager will coordinate 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. They will oversee TMF, CTMS, and database for assigned projects, participate in the development of protocols, ICFs, CRFs, and other study-related documents, and build study budgets and timelines. Additionally, the role requires establishing milestones, coordinating site selection and activation, tracking metrics, and summarizing clinical data for project updates, reports, and publications. The Project Manager will serve as the primary liaison between the sponsor, vendor, sites, and internal cross-functional teams, ensuring project compliance with ICH-GCP guidelines, IRB requirements, FDA regulations, and any other applicable requirements. The role also involves contributing to resource forecasting and management, identifying future potential studies, supporting new technology onboarding, and participating in process improvement initiatives.

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.
• 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.

Nice To Haves

• Experience in IVD or medical device clinical research strongly preferred.
• Clinical research certification (e.g. ACRP, SOCRA) strongly preferred.

Responsibilities

• Manage end-to-end lifecycle of assigned IVD clinical research projects, including startup, site management, monitoring, and closeout.
• Coordinate 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.

Benefits

• 100% Employer-paid medical for single coverage effective on your date of hire
• 50% employer-paid medical for spouse/dependent coverage
• 100% Employer-paid Dental & Vision for entire family
• No cost for employee coverage for Group Term Life, Short- & Long-Term Disability
• 4% retirement contribution
• Employer match
• Incentive Performance Plan
• Stock Option Program
• Commission (Sales Account Execs)
• Paid Family Leave Program
• Generous PTO plan & holiday program
• Flexible work schedule
• Lucrative employee referral program
• Free coffee, snacks and other goodies all day long

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level