Senior Clinical Trial Manager
- Employer
- Fate Therapeutics
- Location
- San Diego, CA
- Start date
- Jul 19, 2022
View more
- Discipline
- Clinical, Clinical Research, Clinical Trials
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach
Job Details
Responsibilities
- Independently manage all components of a clinical trial, leading a cross-functional study management team. The assigned clinical trial may be of high complexity or high risk.
- Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Fate SOPs.
- Lead the identification, evaluation, selection, and oversight of clinical trial sites. Partner efficiently, effectively, and professionally with participating study sites to ensure smooth study conduct.
- Implement strategic operational activities to ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites.
- Review invoices and track study budget according to the forecast working closely with finance and clinical business operations.
- Manage multiple clinical study vendors with oversight of activities.
- Responsible for implementation and oversight of Trial Master File for inspection readiness.
- Develop study documents and tools including study protocols, consent forms, project plans, budgets, logs, templates, newsletters, and other, as needed.
- Provide study status updates and reports to senior management.
- Lead ongoing study data reviews and data cleaning activities.
- Provide oversight of CRAs assigned to clinical trials and provide oversight of activities related to site qualification, initiation, interim monitoring, and close-out visits, as needed.
- Develop and deliver study training to investigators, site staff, and internal staff on select study processes.
- Develop processes and provide oversight of study supplies management.
- Participate in the preparation and follow-up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections.
- Conduct internal meetings for assigned clinical trial(s)
- Conduct external meetings (e.g., Investigator Meetings), conferences and events.
- Participate in RFP and vendor selection process working closely with Clinical Business Operations.
- Train and mentor new clinical trial staff with appropriate delegation and may be responsible for dotted-line management of team members.
- Escalate study issues/risks in a timely manner with solid communication skills.
- May develop SOPs and best practices and facilitate their implementation.
Qualifications
- B.S. degree with minimum 8 years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment.
- Strong leadership, effective decision making, and problem-solving skills required.
- Strong knowledge of and strategic clinical operations. Strong experience with clinical study conduct from start-up through close-out, with global trial and CRO management experience highly preferred.
- Solid tumor, lymphoma or multiple myeloma experience required.
- Immunotherapy or cellular therapy 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 in South San Francisco, California.
- Minimum 10% time traveling to clinical sites and clinical/professional meetings. May include international travel.
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.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. 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 pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
Company
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
- Website
- http://www.fatetherapeutics.com/
- Phone
- 858.875.1800
- Location
-
12278 Scripps Summit Drive
San Diego
California
92131
United States
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