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Clinical Trial Manager
1 week ago
Vera Therapeutics Brisbane, United States**Title: Clinical Trial Manager** · **Location**:Brisbane, CA** · **About Us**: · Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate ...
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Clinical Trial Manager Associate
1 week ago
Vera Therapeutics Brisbane, United States**Title: Clinical Trial Manager Associate** · **Location**:Brisbane, CA** · **About Us**: · Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ...
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Clinical Trial Manager
1 week ago
Fladger Associates Foster City, United StatesResponsibilities: · - Excellent employment opportunity for a Clinical Trials Manager in the Foster City area. Hybrid · - Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all company therapeutic areas. · - Clinical Operation ...
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Clinical Trial Manager
1 week ago
Leadstack Inc Foster City, United States**Job Details**: · LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, ...
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89bio, Inc. San Francisco, United StatesTHE COMPANY · 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically e ...
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89bio San Francisco, United StatesTHE COMPANY · 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically ...
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Clinical Trial Manager
2 weeks ago
EPM Scientific San Francisco, United StatesSalary: · $150K -180K · Company Summary: · A global immunology focused pharmaceutical group with an impressive track record is seeking a Clinical Trial Manager or a Senior Clinical Trial Manager for a hybrid role located in Palo Alto, CA. Their commercial supply of pharmaceutic ...
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Abdera Therapeutics San Francisco, United StatesJob Description · Job Description · Who we are · Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary ...
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89bio, Inc. San Francisco, United StatesTHE COMPANY · 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically e ...
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89bio San Francisco, United StatesTHE COMPANY · 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically ...
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89bio San Francisco, United StatesTHE COMPANY · 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically e ...
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89bio San Francisco, United StatesTHE COMPANY · 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically ...
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Clinical Trial Manager
2 weeks ago
EPM Scientific San Francisco, United StatesSalary: · $140-165K · Company Summary: · A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Clinical Trial Manager for a hybrid role at their San Francisco site. Their commercial supply of pharmaceutical products generated $83m in re ...
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Clinical Trial Manager
1 week ago
The Steely Group San Francisco, United StatesWe are seeking a driven and talented individual to join our client's Clinical Operations team as they change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizing their technology and progressing their novel therapeu ...
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Clinical Trials Manager
1 week ago
Maxonic San Francisco, United StatesMaxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a · Clinical Trials Manager · Job Description: · Job Title: · Clinical Trials Manager · Job Type: · Contract · Job Location: · US , California, USA, ...
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Clinical Trials Manager
1 week ago
LeadStack Inc. San Francisco, United StatesJob Details: · LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we' ...
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Clinical Trial Manager
3 weeks ago
EPM Scientific San Francisco, United StatesJob Description · Job DescriptionSalary: $140-190K · Company Summary: Working with a clinical-stage biotech company that's looking for a Clinical Trial Manager or Sr. Clinical Trial Manager to come into their South SF office on a hybrid/full-time basis. Their mission is to create ...
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Clinical Trials Manager
1 week ago
Madagoni LLC Foster City, United StatesLocation: Onsite in Foster City, Hybrid. · Department: Clinical Operations. · Key Responsibilities · Operational Leadership: · Serve as the primary contact for biomarker and bioanalytical operational activities. · Collaborate with Clinical Operations, Biomarker Sciences, Clinical ...
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Clinical Trial Management Associate
3 weeks ago
Akero Therapeutics San Francisco, United StatesCOMPANY BACKGROUND · Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efrux ...
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Clinical Trial Site Manager
3 weeks ago
Pharma Search Partners San Francisco, United StatesClinical Trials Site Manager, you will be an · essential member of our clinical team. You will lead the study team and be responsible for the execution · of complex clinical trials from study design through study close out. You will be responsible for business · and financial ...
Clinical Trial Manager/Senior Clinical Trial Manager San Francisco, CA - snaphire
Description
Clinical Trial Manager/Senior Clinical Trial ManagerTHE COMPANY
89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases.
The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).THE ROLE
The
Clinical Trial Manager/Senior Clinical Trial Manager (CTM ) will be a key member of the 89bio Clinical Operations team.
The CTM will function as the study team leader to plan, organize and coordinate all operational aspects of a clinical study from protocol development through database lock.
The CTM will ensure timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and all applicable regulations governing the conduct of clinical trials while meeting Company goals and objectives.
THE RESPONSIBILITIES
Responsible for the implementation and quality execution of assigned clinical protocol according to 89bio SOPs, ICH/GCP and corporate and departmental program goals.
Lead or support timelines and budget management to optimize achievement of study goals and milestones.Lead or support CRO/Vendor selection process for outsourced activities, including developing an RFP, managing the bidding process, analysis of proposals, budgets, and leading and documenting vendor selection decisions.
Includes review of Scope of Work, budgets and negotiating contracts through execution.Ensure quality and timely delivery of clinical study data.
Chair or participate in meetings or conference calls with multi-disciplinary study team, regional monitors, or vendors (e.g., CROs, central Labs).
Coordinate activities with other functional groups, such as Regulatory, Safety, Biostatistics, etc.Work with Clinical Research Organizations (CROs) to ensure coordination of Sponsor and CRO responsibilities, obligations are being met.
Lead or support developing critical study documents, including, but not limited to informed consent form templates, various management plans and study trackers.
Maintain strong relationships with site study personnel to ensure site engagement.Monitor site performance on an ongoing basis and escalate any infringements, breaches and misconduct, fraud, and negative trends.
Ongoing protocol deviation tracking, reporting, and trending.
Assist in auditing of clinical trial data for accuracy and consistency and arrange correction of errors as appropriate.
Manage central and/or local labs and supplies.
Coordinate supplies for specimen collection and track shipments of samples for assays.
Document all trial information with adherence to applicable guidelines and SOPs.
Remain current with ICH guidelines, FDA regulations, and company SOPs May contribute to the identification and development of departmental policies.
May recommend and implements innovative processes to improve and impact clinical trial management and deliverables.Lead or support GCP inspection-readiness activities.
Maintain website information per SOP.
Travel up to 25%.
THE QUALIFICATIONS
BA/BS in related life science field, e.g. nursing.
5 or more years of relevant experience.
Global drug development experience in metabolic disorders preferred.
Experience in CRO selection and management including drafting request for proposals (RFPs), bidding process, etc.
In-depth knowledge of FDA regulatory requirements and medical practice/techniques and terminology.
Success working within a team and independently, with minimal supervision.
Willing to travel 25% domestically and international travel.
Strong organizational/prioritization of multiple tasks under tight timeframes with close attention to detail.
Excellent communication and interpersonal skills.
Experience with Phase 1 trials is preferred.
SALARY
89bio considers many factors when determining level and compensation. These considerations mean actual level and compensation will vary. The salary range for this position is $105,000 - $140,000 and will be commensurate with experience.
THE PERKS
Competitive health insurance coverage
Employee Stock Purchase Plan (ESPP)
Women's forum / mentoring
Office based in the heart of San Francisco, near plenty of shops and restaurants
Fun opportunities to engage with co-workers in-person and remotely
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.
Proof of Covid vaccination is a condition of employment.Notice to Recruiters:
To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly.
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Clinical Trial Manager/Senior Clinical Trial Manager San Francisco, CA professionals in San Francisco
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McKenzie Friel
People Operations | HR