Clinical Trial Manager, Inflammation

Proclinical is currently seeking a Clinical Trial Manager for a biotechnology company located in Foster City, CA. Successful candidate will contribute to development of abstracts, presentations, and manuscripts, Ensures effectiveness of site budget/contract process.

Job Responsibilities:

• Coordinating and supervising all aspects of a clinical study.
• Monitoring clinical trial sites. Assisting Clinical Program Manager in overall study management.
• Drafting and coordinating review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
• Maintaining study timelines. Contributing to development of study budget.
• Contributing to development of RFPs and participating in selection of CROs/vendors. Managing CROs/vendors.
• Coordinating review of data listings and preparing interim/final clinical study reports.
• Training CROs, vendors, investigators, and study coordinators on study requirements when asked.
• Assisting in determining the activities to support a projects priorities within functional area.
• Designing scientific communications within the company, under supervision.

Skills and Requirements:

• CTM experience (2+ years' experience, already performing at the CTM level.)
• Biotech/pharma industry experience required.
• Global phase 3 experience is required and Inflammation experience preferable.
• Ability to ramp up to speed quickly.
• Excellent teamwork, communication, decision-making and organizational skills are required.
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Must be able to generally understand, interpret, and explain protocol requirements to others.
• Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Sherron Howard at (+1) 267-435-8600 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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