Clinical Trial Manager

Where

San Francisco, CA

What you'll be doing

Manages clinical study team to ensure that a trial is completed on time, within budget, and in compliance with SOPs, FDA regulations and guidelines. Manages various study team activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports. Manages study sites and trains clinical site staff to ensure protocol and regulatory compliance. Manages portions of the clinical site budgets, CRO selection and assist the contract group in the development of RFPs. Manages staff who oversee multiple contract research organizations (CROs, including clinical services, data management, bio-statistical services, and central laboratory services. Management responsibility for ensuring SOP and regulatory compliance of staff and study teams on one or more trials. Manages study plans, study reports, sections for Investigator's brochures, and regulatory documents (e.g., IND, NDA or BLA) on one or more trials. Manages and direct junior staff i.e.: CRAs / CRA IIs / CTA performing site management efforts. Manages clinical supplies requirement needs determination and ordering supplies for one or more trials. Manages the development of clinical monitoring plans and establishes study monitoring priorities. Manages team administrative issues with investigational sites and/or CROs.

What your background should be

At least 6 years desired in the biotech / pharmaceutical industry or equivalent, and several years of relevant clinical experience in the CRA functional role preferred. 1 year experience as a CTM or equivalent preferred. Knowledge of GCP and ICH guidelines required. Proficiency in the implementation, monitoring, and management of clinical trials. Demonstrated managerial and supervisory skills. Excellent communication and interpersonal skills. Able to problem solve and use good judgment. Able to work within a team and work with general instructions. Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project skills preferred.

Required Schooling / Training

Bachelor's degree in a relevant scientific discipline or equivalent.

Who is the client company

This is a research-based biopharmaceutical company.

If you are interested in this position, send your resume to apply@kochdavis.com