logo

Associate Clinical Trial Manager

  • Anywhere

Company :
Fate Therapeutics, Inc.

Location :
San Diego, California

Expiry Date :
Fri, 16 Apr 2021 23:59:59 GMT

Apply Job :
Open Link

Description :
Description Fate s Clinical Operations team is currently seeking a talented and motivat clinical operations professional to support our Hematology/Oncology clinical trials. The successful candidate must have experience managing trials and a good knowledge of clinical operations, GCP and FDA regulatory environment. Oncology trial experience required. This is a full-time position reporting to the Associate Director, Clinical Operations, and is located at our Company headquarters in San Diego, California or remotely from the San Francisco, California area. Responsibilities: Support primary Clinical Trial Manager with study management and GCP vend oversight in day to day clinical operations. May be responsible for multiple clinical projects in various stages of development. Support study start-up and close-out activities at participating clinical sites. Support study subject enrollment and monitoring activities at participati clinical sites. Coordinate project activities and project goals. Support Trial Master File implementation and maintenance. Assist in the development of study documents and tools including study protocols, consent forms, project plans, budgets, logs, templates, newsletters, and other documents, as needed. Assist in SOP development and best practices and facilitate their implementation. Provide study status updates and reports. Assist in ongoing study data reviews and data cleaning activities. Interact efficiently and professionally with participating study sites staff, internal staff, and other departments to ensure smooth study conduct. Assist primary Clinical Trial Manager in support and oversight of monitor delegated to perform tasks related to site qualification, initiation, interim monitoring, and close-out visits, as needed. Assist in the development and delivery of study training to investigators site staff, and internal staff on select study processes. Assist with study supplies management. Participate in internal meetings for assigned clinical trial(s) and prepa minutes, as necessary. Participate in external meetings (e.g., Investigator Meetings), conferenc and events. Interface with representatives from other key functional groups including research and development, regulatory, quality, and legal as appropriate. Qualifications B.S. degree with minimum 2 years of experience managing clinical trials i biotech, pharmaceutical, and/or CRO environment. Good knowledge of clinical operations and experience with clinical study conduct from start-up through close-out. Oncology experience required (lymphoma or multiple myeloma experience highly preferred). Immunotherapy or cellular therapy experience highly preferred. Clinical site monitoring experience highly preferred. Working knowledge of relevant GCPs and FDA regulations. Experience operating in a matrix organization. Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials. Strong team orientation, with excellent written and oral communication skills. Working Conditions and Physical Requirements May require occasional evening and weekend work Full-time onsite work at Company s headquarters in San Diego or remo from the San Francisco, CA area Up to 25% time traveling to clinical sites and clinical/professional meetings The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. For consideration send cover letter and resume to: and reference job code 402MD. Show moreShow less