Clinical Study Manager - I

At Proclinical, we are seeking an experienced individual to fill the role of Clinical Study Manager - I, based in Foster City, CA.

Responsibilities

• Coordinate and supervise all aspects of a clinical study.
• Assist Clinical Program Manager in overall study management.
• Draft and coordinate review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
• Maintain study timelines.
• Contribute to development of study budget.
• Contribute to development of RFPs and participate in selection of CROs/vendors.
• Manage CROs/vendors.
• Coordinate review of data listings and preparation of interim/final clinical study reports.
• Contribute to development of abstracts, presentations, and manuscripts, Ensures effectiveness of site budget/contract process.
• Train CROs, vendors, investigators, and study coordinators on study requirements where needed.
• Assist in determining the activities to support a project's priorities within functional area.
• Under supervision, may design scientific communications within the company.
• Serve as a resource for clinical trials management expertise.
• Examine functional issues from an organizational perspective.
• Participate in multiple departmental or interdepartmental strategic initiatives.
• Must have a general, functional expertise to support SOP development and implementation.

Skills And Qualifications

• Bachelor's degree or greater.
• Knowledge and understanding of all relevant internal and external guidelines.
• Some travel may be required.

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 Christopher Frank at (+1) 2674056996 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.