What are the responsibilities and job description for the Clinical Study Manager (CSM) position at Joulé?
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 Manager w/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.
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Ref: #568-Clinical