- Manage all components of clinical trial(s), leading a cross-functional study team under the direction of the disease area lead. The assigned trial(s) may be of low- to moderate complexity or risk. May manage assigned components of high complexity or elevated risk, global, and/or pivotal trials under the direction of a senior clinical operations team member.
- Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements and Fate SOP.
- Lead the identification, evaluation, selection, and oversight of clinical trial sites.
- Partner efficiently, effectively, and professionally with assigned Clinical Research Associates (CRA) and participating study sites to ensure smooth study conduct.
- Author and implement operational plans to ensure efficient study enrollment and high-quality monitoring activities at clinical sites.
- Review/approve vendor and site invoices and track study budget to forecast, working closely with finance and clinical business operations.
- Responsible for implementation and oversight of Trial Master File for inspection readiness.
- Drive overall process and provide support to cross-functional teams in the development of study documents including study protocols, consent forms and budget templates.
- Serve as lead in the creation of project plans, logs, templates, newsletters, and other documents.
- Review and approve site specific documents (such as informed consent forms, site budgets, monitoring reports) along with other relevant project team members.
- Provide study updates and reports, inclusive of study risks and issues.
- Lead internal and external meetings for assigned clinical trial(s), including Investigator Meetings, conferences, events, iDMC, and study management meetings.
- Responsible for ongoing study data reviews and data cleaning activities.
- Provide oversight of CTA and CRA activities such as site identification, qualification, selection, initiation, data quality, interim monitoring and close out activities.
- Manage trial-level quality risk management.
- Oversee study supplies management.
- Support the development and complete the delivery of study training to investigators, site staff and internal staff on study processes.
- Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections.
- Lead on-site/remote site booster visits.
- B.S. degree with a minimum of 7 years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment.
- Oncology or autoimmune experience required.
- Immunotherapy or cellular therapy experience preferred.
- Strong working knowledge of clinical operations and experience with clinical study conduct from start-up through close-out, with global trials or CRO management experience preferred.
- Management experience of project teams along with the ability to lead cross functional study teams.
- Experience operating in a matrix organization.
- Effective communication skills and professional demeanor; ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers, medical writers, and internal cross-functional team members.
- Working knowledge of FDA/ICH guidelines and industry/technology standard practices including Good Clinical Practices; trial initiation and management practices and procedures.
- Understanding of pharmaceutical and clinical development processes.
- Strong knowledge of Clinical Operations and experience with clinical study conduct.
- Ability to manage multiple projects and priorities.
- Autonomous ability to work with minimal supervision and meet deadlines.
- Onsite work at corporate headquarters in San Diego, CA.
- Travel may be required.
- Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
- The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
- Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
- The anticipated salary range for this role is $145,000 - $165,000.
-
Clinical Trial Manager
1 week ago
i-Pharm Consulting San Diego, United StatesJob Title: Clinical Trial Manager - Rare Disease · Location: San Diego, CA (Hybrid working model, remote candidates with exceptional qualifications may be considered) · Overview: · Lead the planning, execution and management of clinical trials for innovative rare disease treatmen ...
-
Clinical Trial Manager
2 weeks ago
Boundless Bio San Diego, United StatesBoundless Bio is a publicly traded (Nasdaq:BOLD), San Diego-based, clinical stage oncology company employing an exciting new area of cancer biology, extrachromosomal DNA ("ecDNA"), to revolutionize the way cancer is treated. Reporting to the Associate Director, Clinical Operation ...
-
Clinical Trial Manager
3 weeks ago
Alterome Therapeutics San Diego, United StatesAbout Us: · Alterome Therapeutics, Inc. was formed in December 2021 and officially launched operations in January 2022. We are a precision oncology biotech developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. The company is led by a t ...
-
Clinical Trial Manager
4 weeks ago
Boundless Bio San Diego, United StatesBoundless Bio is a publicly traded (Nasdaq:BOLD), San Diego-based, clinical stage oncology company employing an exciting new area of cancer biology, extrachromosomal DNA ("ecDNA"), to revolutionize the way cancer is treated. Reporting to the Associate Director, Clinical Operation ...
-
Clinical Trial Manager
1 week ago
Equillium Inc San Diego, United StatesOverview of Position: · Managing and meeting the objectives of clinical studies and programs by ensuring successful conduct of assigned clinical programs consistent with applicable regulations, Good Clinical Practice (GCP) and current standard operating procedures (SOPs). Account ...
-
Clinical Trial Manager
3 weeks ago
Alterome Therapeutics San Diego, United StatesAbout Us: · Alterome Therapeutics, Inc. was formed in December 2021 and officially launched operations in January 2022. We are a precision oncology biotech developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. The company is led by a t ...
-
Clinical Trial Manager
1 week ago
iPharm San Diego, United StatesJob Title: Clinical Trial Manager - Rare DiseaseLocation: San Diego, CA (Hybrid working model, remote candidates with exceptional qualifications may be considered)Overview:Lead the planning, execution and management of clinical trials for innovative rare disease treatments at a s ...
-
Clinical Trial Manager
1 week ago
Crinetics Pharmaceuticals, Inc. San Diego, United StatesClinical Trial Manager · Categories: Clinical Operations · Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists wit ...
-
Clinical Trials Manager
2 weeks ago
Kaiser Permanente San Diego, United States: Job Summary: · The Clinical Research Manager is a demonstrated expert operational leader position, which is responsible for overseeing the daily research activities of multiple FDA-regulated clinical trials and clinical research projects at multiple KPSC sites. The Clinical Re ...
-
Clinical Trial Manager
2 weeks ago
Alterome Therapeutics San Diego, United StatesJob Description · Job DescriptionSalary: $130,000 - $160,000/year based on skills and experience. · About Us: · Alterome Therapeutics, Inc. was formed in December 2021 and officially launched operations in January 2022. We are a precision oncology biotech developing alteration-sp ...
-
Clinical Trial Manager
4 days ago
Crinetics Pharmaceuticals San Diego, United StatesClinical Trial Manager · Categories: Clinical Operations · Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists wit ...
-
Senior Clinical Trial Manager
1 day ago
Tr1X San Diego, United StatesPosition Description · The Senior Clinical Trial Manager will play a key contributor role in the implementation and execution of clinical trial(s) from study start up to close-out. The incumbent will have responsibilities for the management and oversight of CRO's, study vendors a ...
-
Clinical Trial Manager II
3 weeks ago
Fate Therapeutics, Inc. San Diego, United States Full timeFate Therapeutics is looking for a talented Clinical Operations professional to support our clinical studies. This position offers an excellent opportunity for a highly motivated individual to contribute to the successful coordination and execution of clinical studies with our iP ...
-
Clinical Trial Manager, Oncology
3 weeks ago
Planet Pharma San Diego, United StatesWe are working with a growing San Diego pharmaceutical client looking to hire a Clinical Trial Manager. The position is an initial 6 month (extendable) contract and they would like this person to work on-site 3 days a week. · RESPONSIBILITIES: · Contribute to the operational stra ...
-
Sr. Clinical Trials Manager
2 weeks ago
Artiva Biotherapeutics San Diego, United StatesAbout Artiva: · Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Our mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases ...
-
Clinical Trial Manager II
2 weeks ago
BioSpace San Diego, United StatesJob Details · Fate Therapeutics is looking for a talented Clinical Operations professional to support our clinical studies. This position offers an excellent opportunity for a highly motivated individual to contribute to the successful coordination and execution of clinical studi ...
-
Clinical Trial Manager II
3 weeks ago
BioSpace San Diego, United StatesJob Details · Fate Therapeutics is looking for a talented Clinical Operations professional to support our clinical studies. This position offers an excellent opportunity for a highly motivated individual to contribute to the successful coordination and execution of clinical studi ...
-
Senior Clinical Trial Manager
2 weeks ago
EPM Scientific San Diego, United StatesSenior Clinical Trial Manager · San Diego, CA (Hybrid) · $160,000 - $180,000 · Job Description · EPM is partnered with a trailblazing biotech nestled in sunny San Diego, dedicated to pioneering breakthroughs at the intersection of oncology and immunology. Leveraging cutting-edge ...
-
Senior Clinical Trial Manager
1 week ago
EPM Scientific San Diego, United StatesSenior Clinical Trial Manager · Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants. · San Diego, CA (Hybrid) · $160,000 - $180,000 · Job Description · EPM is partnered with a trailblazing biotech nestled ...
-
Sr Clinical Trial Manager
3 weeks ago
Erasca, Inc. San Diego, United StatesErasca?is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MA ...
Clinical Trial Manager II - San Diego, United States - Fate Therapeutics, Inc.
Description
Fate Therapeutics is looking for a talented Clinical Operations professional to support our clinical studies.This position offers an excellent opportunity for a highly motivated individual to contribute to the successful coordination and execution of clinical studies with our iPSC platform.
This role is expected to manage and oversee all study-level vendor and site related activities and issues related to one or more clinical trials, as needed.
The successful candidate must have experience managing Phase I-III trials and a good knowledge of clinical operations, GCP, and FDA regulatory environment.
This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.Responsibilities
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.
Equal Employment Opportunity
Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
Privacy Notice
To learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice.
About Fate Therapeutics, Inc.
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 diseases.
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
Clinical Trial Manager II professionals in San Diego
-
Brianna Monge
Medical Assistant
-
Audrey Radi
Business and IT Manager - Asia Pacific Focus
-
Taylor Barkdoll
Project Manager drug development
-
Martin Furey
Nonprofit Leadership, Development, and Operations
-
Sophi Bristow
Aspiring Speech-Language Pathologist
-
Andrea Cole Raub
Experienced Physician Certified Family Practice