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Senior Clinical Trial Manager
- Contract
- Program Manager / Director
- United States
This vacancy has now expired. Please see similar roles below...
Proclinical is currently recruiting for a Senior Clinical Trial Manager for a leading global pharmaceutical company located in South San Francisco, CA. Successful candidate will have at least 5 years of similar experience.
Job Responsibilities:
- Serve as the key operational contact with external investigators and internal stakeholders.
- Ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility and fair market value assessment.
- Establish strong partnerships with external investigators and collaborators to ensure ongoing activities for CO and ISR studies are executed in a timely manner and with high quality.
- Establish strong cross-functional relationships and exhibit strong leadership skills with counterparts in other functional teams to ensure efficient execution of the study management processes.
- Maintain a good understanding of industry standards and regulations for CO and ISR studies and keep abreast of any new changes and developments impacting Late Phase clinical operations.
- Organize and lead clinical operational meetings.
- Maintain internal Clinical Operations databases and document repositories.
- Draft and coordinate review of relevant documents including protocols, informed consents, case report forms, monitoring plans, and clinical study reports.
- Must be able to understand, interpret and explain protocol requirements to others.
- Maintain study timelines.
- Coordinate review of data listings and preparation of interim/final clinical study reports.
- May be asked to train CROs, vendors, investigators and study coordinators on study requirements.
- Contribute to development of study budget.
Skills and Requirements:
- BS/BA with at least 5 years of experience.
- Provides knowledge and expertise on country specific regulations, site experience, and suitability for development studies.
- Excellent teamwork, communication, decision-making and organizational skills are required.
- Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
- Working knowledge and experience with Word, PowerPoint and Excel.
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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