Associate Clinical Trial Manager

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

Job Responsibilities:

• Serves as the key operational contact with external investigators and internal stakeholders.
• Has ability to evaluate a scientific proposal or protocol to identify logistical, regulatory and safety implications.
• Acts as primary contact for study drug planning and shipping with Materials & Logistics.
• Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
• Forecasts, tracks and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment.
• Provides monthly study updates to the appropriate internal stakeholders.
• Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.
• Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
• In collaboration with the Clinical Program Manager (CPM), provides training for new hires, as applicable.
• Provide support and guidance, as required, to Affiliate Clin Ops & Medical Affairs personnel responsible for managing CO and ISR studies.
• Maintains a good understanding of industry standards for CO and ISR studies and keeps abreast of any new changes and developments which could impact Late Phase research operations.
• Organizes and leads review/approval meetings for CO proposal.
• Actively participates in Clinical Operations Quality Initiatives.
• Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.
• Performs administrative duties in a timely manner as assigned.
• 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.
• May resolve routine monitoring issues.
• Assists in the setting and updating of study timelines.
• Assists in CRO or vendor selection.
• With guidance from supervisor coordinates CROs or vendors.
• May assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports.
• Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
• 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 other clinical team members.
• Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
• Travel is required.

Skills and Requirements:

• Bachelor's degree in Science with relevant project management experience, or equivalent/advanced Degree in science with relevant project management experience
• Minimum 3-5 years pharmaceutical industry experience with knowledge of drug development process.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
• Good understanding of financial systems and contracting process (desirable, but not required).
• Ability to understand clinical study protocols and efficient project management skills
• Working knowledge of ICH/GCP required. Phase research experience preferred.
• Working knowledge of MS Word, PowerPoint, Outlook, and Excel.
• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials and ability to understand clinical study protocols
• Ability to collaborate with others to complete assigned tasks.

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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