Associate Clinical Trial Manager
Company: Fate Therapeutics, Inc.
Location: San Diego
Posted on: November 23, 2020
Associate Clinical Trial Manager Job Code 402MD Description Fate
s Clinical Operations team is currently seeking a talented and
motivated 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 s headquarters in San Diego, California or remotely from
the San Francisco, California area. Responsibilities: Support
primary Clinical Trial Manager with study management and GCP vendor
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 participating 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 monitors 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 prepare minutes, as necessary.
Participate in external meetings (e.g., Investigator Meetings),
conferences 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
in 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 remotely 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. About Fate
Therapeutics, Inc. Fate Therapeutics is a clinical-stage
biopharmaceutical company dedicated to the development of
first-in-class cellular immunotherapies for cancer and immune
disorders. The Company has established a leadership position in the
clinical development and manufacture of universal, off-the-shelf
cell products using its proprietary induced pluripotent stem cell
(iPSC) product platform. The Company s immuno-oncology product
candidates include natural killer (NK) cell and T-cell cancer
immunotherapies, which are designed to synergize with
well-established cancer therapies, including immune checkpoint
inhibitors and monoclonal antibodies, and to target
tumor-associated antigens with chimeric antigen receptors (CARs).
The Company s immuno-regulatory product candidates include ProTmune
, a pharmacologically modulated, donor cell graft that is currently
being evaluated in a Phase 2 clinical trial for the prevention of
graft-versus-host disease, and a myeloid-derived suppressor cell
immunotherapy for promoting immune tolerance in patients with
immune disorders. Fate Therapeutics is headquartered in San Diego,
CA. For more information, please visit .
Keywords: Fate Therapeutics, Inc., San Diego , Associate Clinical Trial Manager, Executive , San Diego, California
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