Clinical Trial Management Associate

Proclinical is currently recruiting for a Clinical Trial Management Associate with a pharmaceutical company located in San Mateo, CA.

Job Responsibilities:

• With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
• Assures site compliance with the routine protocol and regulatory requirements and quality of data.
• Assists in the setting and updating of study timelines.
• Assists in CRO or vendor selection.
• With guidance from supervisor coordinates CROs or vendors.
• Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
• Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
• Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
• May participate in abstract presentations, oral presentations and manuscript development.
• Interfaces 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. T
• ravel is required.

Skills and Requirements:

• Excellent verbal, written, interpersonal and presentation skills are required.
• 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.

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

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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