Sr. Clinical Trials Manager

Proclinical is currently seeking a Senior Clinical Trial Manager for a biotechnology company located in Foster City, CA. Successful candidate will provide guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.

Job Responsibilities:

• Write study protocols, study reports, sections for investigator brochures and regulatory documents.
• Contribute to development of presentations.
• Partner with functional peers to manage, adjust, and revise project timelines/budgets as necessary.
• Communicate project status and issues and ensure project team goals are met.
• Design and use all available vehicles for scientific communication within company. Participate in or lead departmental strategic initiatives
• Anticipate moderately complex obstacles and client difficulties and implement solutions to achieve project goals.
• Resolve problems using national and international regulations, guidelines and investigator interaction Participate in and/or lead departmental or interdepartmental strategic initiatives.
• Initiate, author, or contribute to SOP development, implementation and training.
• Examine functional issues from a broader organizational perspective.

Skills and Requirements.

• 7+ years of experience and a BS/BA, or higher, in a relevant scientific discipline.
• 7+ years of experience and an RN (2 or 3 year certificate).
• Excellent interpersonal skills and demonstrated ability to lead is required.
• Experience in developing RFPs and selection and management of CROs/vendors.
• Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.
• Strong communication and influence skills and ability to create a clear sense of direction is necessary.
• Thorough knowledge and understanding of FDA and/or EMA Regulations, ICH.Guidelines, and GCPs governing the conduct of clinical trials is 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 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.

Proclinical Staffing is an equal opportunity employer.

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