Clinical Program Manager
ProClinical is advertising a vacancy for a Clinical Program Manager position with a leading pharmaceutical research company. The organization prides itself on its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. Based in the company's California office, this is an exciting opportunity to work with an internationally renowned company and support their innovative impact on the healthcare field.
- Ability to write study protocols, study reports, sections for investigator brochures and regulatory documents (e.g. IND, NDA, etc.) with little supervision
- Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials
- Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
- Draft protocols and completely understand the process
- Communicates project status and issues and ensure project team goals are met
- Experience in developing RFPs and selection and management of CROs/vendors
- Functional expertise to initiate, author, or contribute to SOP development, implementation and training
Skills and Requirements:
- At least 6 - 7 years of experience and a BS or BA in a relevant scientific discipline
- At least 6 - 7 years of experience and an RN (2 or 3 year certificate)
- Thorough knowledge and understanding of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required
- VeevaVault experience, preferable
- Microsoft Suite especially project is required
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Sherron Howard at +267 435 8600 or upload your CV 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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