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Equillium
San Diego
Job Description Job Description Salary: 130,000-150,000 Overview 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). Accountable for meeti
Job Source: EquilliumFate Therapeutics, Inc.
San Diego, CA, United States
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-lev
Job Source: Fate Therapeutics, Inc.Crinetics Pharmaceuticals, Inc.
San Diego, CA, United States
Senior Clinical Trial Manager Categories: Clinical Operations Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with rare endocrine diseases. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to be
Job Source: Crinetics Pharmaceuticals, Inc.BioPhase
San Diego, CA, United States
BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Life Sciences community. We are currently looking for an ONSITE Sr. Clinical Trial Manager to work for a leading San Diego area biotech company. *Must be local to San Diego, CA. Key Responsibilities: · Oversee the performance of CROs and third-party
Job Source: BioPhaseCalibr-Skaggs Institute for Innovative Medicines, A Division of Scripps Research
San Diego, CA, United States
POSITION TITLE : Senior Clinical Trial Manager ABOUT US Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, is a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr-Skaggs was founded on the principle that the creation of new medicines can be ac
Job Source: Calibr-Skaggs Institute for Innovative Medicines, A Division of Scripps ResearchTr1X
San Diego, CA, United States
Position 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 and clinical trial sites, and will partner key internal stakeholders to e
Job Source: Tr1XTr1X
San Diego
Job Description Job Description Tr1X ("Trix") is a biotechnology company focused on engineering cures for autoimmune and inflammatory diseases. The company develops cellular therapies with the potential to cure disease by inducing immune tolerance and restoring homeostasis. Tr1X has a state-of-the-art technology platform that allows for the sc
Job Source: Tr1XArtiva Biotherapeutics
San Diego
Job Description Job Description Salary: About 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 and cancers. Our lead program,
Job Source: Artiva BiotherapeuticsSan Diego, CA, United States
Boundless 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 Operations we are seeking a Clinical Trial Manager (CTM) who will be an essential contributor to our BBI-355 program with a strong pipeline following. The successful candidate is an independent self-starter with strong attention to detail. Open to hybrid/remote work schedule.
Duties and Responsibilities:
In partnership with CROs, provide guidance and daily oversight for the successful management of all aspects of global oncology trials
Perform operational management of study PK/PD samples and drug supply at study sites for 355
Support Associate Director, Clinical Operations for monthly subject accruals
Coordinate with legal and follow-up on all outstanding matters for 355 (new contracts, CTAs, CDAs)
Tracking/admin support for Lilly & Taiho Clinical Supply Partnerships
Monitor the progress of trials including enrollment and clinical trial material inventory
Develop protocols, consent forms, IRB/EC materials, and other trial documents
Assist in case report form (CRF) development and programming of electronic data capture
Participate in the process of site and vendor selection and qualification
Prepare or review and approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, monitoring plans, and monitoring reports.
Provide study updates at clinical operations meetings-including updating other clinical staff and upper management on patient recruitment, trial issues, investigator’s feedback, monitoring issues, patient enrollment issues and presenting a plan of action for resolution of issues
Act as cross-functional liaison to ensure study plans remain aligned with current business development strategies.
Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.
Education/Experience:
Bachelor’s degree in a scientific or health related field or equivalent combination of education and experience
5+ years of experience directly supporting clinical research trials or relevant equivalent experience
Analytical problem-solving experience, including the ability to anticipate and resolve obstacles with strong reasoning skills
Excellent organizational skills and attention to detail
Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and US FDA regulations
Effective communication and interpersonal skills; ability to build relationships internally and externally
Cross functional and cross-cultural awareness, someone who seeks out diverse perspectives and considers these perspectives in making decisions
Patient-centric philosophy towards research
Ability to thrive in an entrepreneurial, fast-paced, and dynamic work environment
Familiarity with medical terms
Demonstrated writing skills to deliver messages effectively so messages are clearly understood
Demonstrated expertise with PCs and standard Microsoft Office software applications
Up to 20% travel
The anticipated annual salary range for this position is $135,000 to $165,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. In addition to base salary, BBI employees are eligible for an annual bonus incentive, and an equity stock option grant. BBI offers a competitive benefits package including, medical, dental, vision, and life insurance for employees and their dependents. We also offer and an Employee Stock Purchase Plan (ESPP) and a 401(k) plan with a matching contribution in addition to a flexible time off policy.
Boundless Bio fosters an inclusive company culture that values diverse talent, backgrounds, and experiences. We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories.
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Clinical Trial Manager jobs in San Diego, CA, United States
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