Clinical Study Manager (CSM)

System One; Cleveland (OH); Remote; USD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company is seeking a Clinical Study Manager (CSM) to oversee and manage clinical trials, ensuring compliance with regulatory frameworks. The ideal candidate should have over 5 years of experience in a pharmaceutical setting, a robust understanding of the clinical study process, and the ability to thrive in a fast-paced environment. This position offers competitive compensation and the opportunity to work remotely within central/Mid USA.

Benefits

Health insurance

Dental insurance

Vision insurance

401(k) plan

Qualifications

• 5-8 years’ experience in clinical study management.
• Strong working knowledge of GCP, ICH, FDA regulations.
• Experience in CRO/vendor management and finance management.

Responsibilities

• Oversee and manage clinical studies according to regulations.
• Ensure effective communication and resolution of clinical issues.
• Manage budgets, contracts, and site/vendor coordination.

Skills

Communication

Interpersonal Skills

Organizational Skills

Problem Solving

Attention to Detail

Education

University/college degree (BS/BA/MS)

Tools

MS Office

MS Project

EDC

eTMF

Job description

Job Title: Clinical Study Manager (CSM)
Type: Contract -6 month renewable
Compensation: 50-70/hr depending on experience
Contractor Work Model: Remote with a preference of central/Mid USA

Leading Pharmaceutical Company is hiring a Clinical Study Managerw/5+years industry experience.If you want to be a part of this groundbreaking work, please apply!

Experience and Skills:

• The successful candidate must have strong communication, interpersonal and organizational skillsMust have the ability to function independently, be flexible, detail oriented, and work effectively on a team with a high degree of professionalism

• Previous study management experience is required

• The ideal candidate will have a strong working knowledge of the clinical trial process as well as GCP, ICH and FDA regulations and guidelines of clinical trials

• A working understanding of clinical operations and drug development

• The candidate must be able to work effectively in a fast-paced environment and balance multiple priorities in a timely manner

• Must have experience in effectively troubleshooting and resolving clinical issues. Computer skills (MS Office, MS Project, EDC, eTMF, etc.)

• Finance management (budgets, contracts, invoices)

• TMF management/oversight

• Site management

• CRO/Vendor management

• University/college degree (BS/BA/MS) or certification in a related health profession from an appropriately accredited institution

• Strong word processing and computer (Word, Excel, Power-Point, etc.) skills are a must

• 5 – 8 years’ experience is required, including 2-3 years of working in a pharmaceutical setting

• Cell/Gene Therapy and Rare disease

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M-
#LI-
#DI-

Ref: #568-Clinical