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Job #02978

About our client Our client is a young venture-backed biotechnology company that is focused on the development and commercialization of small-molecule therapeutics to treat cancer and eye diseases. The company has a deep pipeline, an exceptional management team and an empowering corporate culture that is focused on rewarding all employees as the business succeeds; this is a great opportunity for the right candidate. Position Location Clinical Trial Manager San Francisco, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee work assignment and deliverables for CROs, independently contracted managers and/or other specified resources 2) Manage investigative site activities by overseeing contracted activities, pre-study site evaluations, site initiations, interim monitoring and closeout 3) Meet clinical operational timelines (study start-up to completion of clinical study report) 4) Provide clinical monitoring input for clinical program plans, protocols and timelines for assigned projects 5) Manage all site-related study start-up activities (Investigator recruitment and selection, collection of regulatory documents, IRB/EC submissions, etc.) 6) Coordinate and create necessary materials to train investigative site personnel and CRAs on clinical trials (as necessary) 7) Confirm investigative site’s adherence to regulations regarding protection of subject's rights and safety through reviewing monitoring reports, QA-GCP audits and communication with CRO CRAs, CRO Project managers, etc. 8) Oversee the collection and validation of all study and site-specific regulatory documentation necessary for initial drug shipment and filing to the IND and NDA 9) Assign, manage and track the completion, quality and timeliness of tasks as well as deliverables for CROs 10) Evaluate CRO performance via co-monitoring visits and document in co-monitoring visit reports 11) Plan, track and conduct follow-ups on all site GCP audits as well as vendor audits (as required) 12) Coordinate and generate necessary materials for clinical trial initiation 13) Contribute to generation, refinement and maintenance of Clinical Affairs infrastructure (primarily SOPs and work instruction guidelines) Requirements 1) Bachelor's degree in a scientific or health-related field 2) Minimum 5 years of clinical research experience (in a biotech, pharmaceutical or CRO company) 3) Minimum 2 years of experience as a CRA 4) Expertise in all aspects of clinical operations, monitoring and overseeing contract resources 5) In-depth knowledge of ICH and FDA GCPs as well as US IND and NDA regulations 6) Therapeutic experience and knowledge of oncology and/or ophthalmology 7) Excellent organizational and communication (written and oral) skills 8) Highly self-motivated 9) Ability to work effectively with minimum supervision 10) Ability to build consensus in a team setting 11) Ability to work with peers from different functional areas and facilitate team objectives