To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02831

About our client Our client is a leading biotech company headquartered in California that is focused on the development and commercialization of gene therapeutic solutions. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Clinical Trial Manager/Project Manager Richmond, California (Bay) Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist with designing, planning and implementation of clinical research projects 2) Manage the development of protocols, CRFs, ICFs, study manuals and study budgets 3) Negotiate and finalize site contracts and budgets 4) Manage and calculate site payments 5) Perform site visits, including site qualification, initiation, monitoring and closeout visits 6) Hire, train and supervise regional monitors and review monitoring reports 7) Ensure that the sites comply with study protocol (to ensure accurate and complete data collection) and federal regulations 8) Represent the company in a professional manner 9) Establish and maintain good relationships with investigators and study site personnel 10) Maintain frequent site contact 11) Prepare, track and manage required study documentation as well as supplies 12) Oversee and track project progress at assigned sites (patient status, safety/adverse events, CRF completion, payments, study drug supply, regulatory documents) 13) Review data listings on an ongoing basis 14) Determine and oversee site drug requirements and accountability as well as other supply requirements 15) Plan and coordinate Investigator meetings 16) Assist with preparing interim study analyses, annual reports and clinical study reports 17) Manage external vendors 18) Develop study specifications and finalize vendor (CROs, central laboratories, IVRS, etc.) contracts Requirements 1) BA/BS degree in Nursing, Pharmacy, Life Sciences or a health-related discipline 2) 5 – 7 years of experience in planning and overseeing clinical trials for a biotech company 3) In-depth knowledge of GCP, ICH and FDA regulations 4) Superb interpersonal and organizational skills 5) Ability to function independently or as part of a team 6) Self-motivated and assertive 7) Detail-oriented, with ability to multi-task and work effectively in a fast-paced environment 8) Demonstrated ability to independently supervise a clinical trial (from initiation to close) as per regulations and with company policies and procedures 9) Excellent communication skills (written and verbal) 10) Willingness to travel (30% – 40%)