An exciting opportunity has arisen for a Clinical Trial Management Assoc I to join a global biopharmaceutical company based in Foster City, CA. A very patient-focused company, who scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
- Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Monitors fairly routine study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
- Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
- May assist in compilation of investigator brochures under close supervision.
- May resolve routine monitoring issues. Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
Skills and Requirements:
- Excellent verbal, written, interpersonal and presentation skills are required.
- Must be familiar with routine medical/scientific terminology.
- Must be familiar with Word, PowerPoint, and Excel. Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
- Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.
- Must be able to contribute to SOP development.
- 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 Hannah Cihlar on +1 267-983-0133 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.