Senior Clinical Trials Manager

Proclinical is currently recruiting for a Senior Clinical Trials Manager position located in the Southern San Francisco, CA area with one of the world's leading pharmaceutical companies. A successful candidate will have at least 5 years of experience, specifically with Phase II studies, and a Bachelor's degree.

Job Responsibilities:

• In partnership with CPMs, provide guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
• Coach members of a work team and ensure adherence to established guidelines.
• Provide input to program budget and timelines to ensure successful management of all aspects of international clinical trials.
• Anticipate obstacles and client difficulties and implement solutions to achieve project goals.
• Assist CPM in revising project timelines/budgets as necessary.
• Work with management on departmental issues, provide input to clinical operations strategies and work plans.
• Communicate with functional peers regarding project status and issues and ensure project team goals are met.
• Contribute to development of abstracts, presentations and manuscripts.
• Participate in the recruiting and hiring process for CPA/CRAs and support their professional development.
• Participate in training of CPAs and CRAs.
• Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.

Skills and Requirements:

• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
• Experience in developing RFPs and selection and management of CROs/vendors.
• Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision.
• Ability to examine functional issues from a broader organizational perspective.
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
• Must meet all requirements for Clinical Trials Manager and have demonstrated proficiency in all relevant areas.
• Excellent interpersonal skills and demonstrated ability to lead is required.
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Strong communication and influence skills and ability to create a clear sense of direction is necessary.
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.
• Travel 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 Catherine Nguyen at (+1) 215-531-5643 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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