Top 5 Clinical research manager Jobs in Cleveland Oh

Clinical Study Manager
Cleveland Diagnostics Inc. —Cleveland, OH
- $90,000 - $120,000 a year
- Urgently hiring
- 5 years
- Computer literacy
- HIPAA
- Paid holidays
- Disability insurance
Medical Lead, Obesity Medicine
Cleveland Clinic —Cleveland, OH
- $95,000 - $144,500 a year
- Full-time
- Medicine
- Surgery
- Perioperative Care
- Health insurance
- Dental insurance

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Clinical Study Manager
Cleveland Diagnostics Inc. —Cleveland, OH
Bachelor's degree in a health or science field required. Coordinate IRB submissions, laboratory shipments and incoming samples, sample receipt logging, kit…
$90,000 - $120,000 a year

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Clinical Study Manager

Cleveland Diagnostics Inc.
Cleveland, OH

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Job Details

$90,000 - $120,000 a year

Benefits

Stock options
Paid holidays
Disability insurance
Health insurance
Dental insurance
Paid time off
Family leave
Snacks provided
Dependent health insurance coverage
Vision insurance
Flexible schedule
Referral program
Retirement plan

Qualifications

FDA submissions
Computer operation
GLP
HIPAA compliance
Computer literacy
HIPAA
ICH guidelines
Bachelor's degree
Research safety & compliance
Communication with regulatory authorities for clinical trials
Computer skills
Clinical quality assurance standards
Clinical confidentiality policies
Ethical review application preparation

Full Job Description

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

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.

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clinical research manager jobs in cleveland oh

Clinical Study Manager

Medical Lead, Obesity Medicine

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