Clinical Trials Manager
ProClinical is advertising a vacancy for a Regulatory Submissions Associate 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.
- Oversees all operational aspects of assigned clinical trial(s).
- Ability to write study protocols, study reports, sections for investigator brochures and regulatory documents (e.g. IND, NDA, etc.) with little supervision
- Oversees clinical trial conduct including study start-up, enrollment, study conduct and close-out.
- Prepares and reviews study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters) and regulatory documents (e.g. IND, NDA, etc.) with little supervision
- Works with CRO to develop and revise study specific plans and detailed timelines, and ensure that transferred obligations and performance expectations are met.
Skills and Requirements:
- At least 3 - 5 years of experience related clinical trial management and a BS or BA in a relevant scientific discipline
- Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
- Vendor management experience preferred
- EDC and/or eTMF (VeevaVault) experience strongly preferred
- Previous management and clinical operations experience
- 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.
Foster City, California
ProClinical is advertising a vacancy for a Senior Clinical Trials Management Associate position with a leading pharmaceutical research company.
A leading global pharmaceutical company has a new vacancy for a eTMF Specialist to join their expanding Zurich team.
ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Clinical Study Assistant position.