Clinical Trial Manager
Clinical | Mountain View, CA | Full Time
ChemoCentryx is searching for a Clinical Trial Manager (CTM) that will be a key member of our Clinical Operations Team. The CTM will report to the Executive Director of Clinical Operations and will work out of our Mountain View offices and then starting in April out of our brand new state-of-the-art corporate center in San Carlos, CA,
The Clinical Trial Manager is a critical role on our cross-functional study management teams and will be responsible for the day-to-day management of ChemoCentryx clinical trials, including management of contract research organizations (CROs) conducting company sponsored clinical trials.
The Clinical Trail Manager will:
- Work with CROs to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed.
- Oversee monitoring activities at clinical CROs by reviewing visit reports, protocol deviations and CAPAs and attend co-monitoring visits as directed.
- Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable.
- Review and contribute to study Protocols, CRF completion guidelines, laboratory manuals, Informed Consent Forms, and other study-related documents.
- Coordinate investigator meetings and/or site and CRA training.
- Perform financial management, including review of site and vendor invoices.
- Track and coordinate trial related materials, including clinical trial supplies and laboratory samples.
- Perform, review and QC central clinical files and trial master file.
- Identify potential study issues and recommend and implement solutions or corrective actions as needed.
- Serve as a liaison and resource for investigational sites; review investigator contracts and site payments.
- Travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
- Perform sponsor oversight and co-monitoring visits.
- Organize and manage internal team meetings and other trial-specific meetings.
- Participating in the development, review and implementation of departmental SOPs and processes.
- Bachelor’s degree or equivalent in a scientific or health care field.
- 4+ years of clinical trial management experience preferably with experience as a CTM, with prior study monitoring experience and knowledge in study site logistics.
- Experience in all phases of study management from start-up through study close out, including protocol development, ICF creation, site feasibility/start up and tracking budget scope, safety reporting, data cleaning and generating CSR.
- Experienced in vendor management.
- Demonstrated knowledge of basic data management, including working with EDC, biostatistics and pharmacovigilence activities.
- Knowledge and ability to interpret and implement FDA regulations, ICH GCP guidelines and other regulations is required.
- Previous experience working in global studies.
- Experience in managing oncology clinical trials and/or orphan disease indications.
- Ability to travel as needed (up to 15%).
ChemoCentryx is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives.
At ChemoCentryx, our salary and benefits packages are among the most competitive in the industry. All our employees share the rewards of their work through a generous stock option program. We also offer 401K and Flexible Spending Accounts. ChemoCentryx employees enjoy a comprehensive benefits package including medical, dental and vision coverage as well as life insurance, and short and long-term disability insurance.