Clinical Trials Management Associate - II

Foster City, CA Contract Duration: 6-18 months Rate: Negotiable Salary: NA $1.00 Responsibilities: Excellent employment opportunity for a Clinical Trials Management Associate - II in the Foster City, CA area. Manages assigned studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements and financial or company product support are processed in a timely manner and to high quality. Maintains efficient collaboration with company's Clinical Contracts and Finance (CCF) team and external investigator/study representative to ensure contracts are executed in timely manner. Acts as primary contact for study drug planning and shipping with Materials & Logistics. 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. 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 CRO or vendor selection. With guidance from supervisor coordinates CROs or vendors. Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies. May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants. Travel is required. Experience: 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. Ability to develop tools and processes that increase measured efficiencies of the project. Effective communication skills, both oral and written. 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.

Created: 2026-04-15