Clinical Trials Management Associate - II
Proclinical is recruiting for a Clinical Trials Management Associate - II position with an international biopharmaceutical company located in Foster City, CA. Successful candidate will assure site compliance with the routine protocol and regulatory requirements and quality of data.
- Assist in the setting and updating of study timelines.
- Assist in CRO or vendor selection.
- With guidance from supervisor coordinate CROs or vendors, Draft and coordinate review of protocols, informed consents, case report forms and monitor plans.
- Assist in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
- Participate or effectively run meetings and conference calls with CROs, vendors, and multi-functional teams.
- May participate in abstract presentations, oral presentations and manuscript development.
- Interface with individuals in other functional areas to address routine study issues.
- May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
- Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
Skills and Requirements:
- Must meet all requirements for Clinical Trials Management Associate II position and have demonstrated proficiency in all relevant areas.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Must have a general understanding of functional issues and routine project goals from an organizational perspective.
- Working knowledge and experience with Word, PowerPoint and Excel.
- Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
- Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
- Ability to develop tools and processes that increase measured efficiencies of the project.
- Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
- Travel is required.
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 Brendan Thalheimer at (+1) 215-531-5299 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.