Clinical Study Manager

Our team is growing, and we currently have an immediate opening for a Clinical Study Manager

Title: Clinical Study Manager

Location: Onsite (Cleveland, Ohio)

Reports to: Director, Clinical Operations

Job Description: 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. 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.

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

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Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee's well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.

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 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
• Salary range may vary by work state/geographical region/territory
• Easy to get to office location with newly built-out office space
• Free coffee, snacks and other goodies all day long

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company's status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.

Compensation details: 90000-120000 Yearly Salary

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