89Bio
Senior Clinical Trial Manager (Contract)
89Bio, San Francisco, California, United States, 94199
Senior Clinical Trial Manager (Contract)
Join to apply for the
Senior Clinical Trial Manager (Contract)
role at
89bio Senior Clinical Trial Manager (Contract)
1 day ago Be among the first 25 applicants Join to apply for the
Senior Clinical Trial Manager (Contract)
role at
89bio Get AI-powered advice on this job and more exclusive features. Direct message the job poster from 89bio 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco. THE ROLE The
Senior Clinical Trial Manager Contractor
will be a key member of the 89bio Clinical Operations team. The Contractor will function as the study team leader to plan, organize and coordinate assigned operational aspects of a clinical study from protocol development through database lock. The Contractor 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. SPECIAL ADVISORY The FTC has an advisory out on the domain 89biocareers.com if you are contacted by any group using a similar, but not our exact domain 89bio.com, please Report any Scams 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 for assigned regions Lead or support CRO/Vendor selection process for assigned 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 May 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 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 Travel up to 25% THE QUALIFICATIONS BA/BS in related life science field, e.g. nursing or equivalent years of experience. 8-12 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 & LEVEL 89bio considers a range of factors when determining hourly rate and level. These considerations mean actual hourly rate and level may vary. The consultant hourly range for this position based on the primary location for this position in Northern California is $80/hour to $120/hour and will be commensurate with expereince. 89bios role/level assessment approach involves assessing candidates during the interview process before confirming the level/title designation. The level assessment is considered on a case-by-case basis. Offer and level is based on factors such as: education, experience, qualifications, geographic location, transferable skills, licenses/certifications and other job-related factors permitted by law. 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. 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. All recruitment is managed through the 89bio Talent Acquisition Team. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Research and Science Industries
Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at 89bio by 2x Sign in to set job alerts for Clinical Trial Manager roles.
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Join to apply for the
Senior Clinical Trial Manager (Contract)
role at
89bio Senior Clinical Trial Manager (Contract)
1 day ago Be among the first 25 applicants Join to apply for the
Senior Clinical Trial Manager (Contract)
role at
89bio Get AI-powered advice on this job and more exclusive features. Direct message the job poster from 89bio 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco. THE ROLE The
Senior Clinical Trial Manager Contractor
will be a key member of the 89bio Clinical Operations team. The Contractor will function as the study team leader to plan, organize and coordinate assigned operational aspects of a clinical study from protocol development through database lock. The Contractor 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. SPECIAL ADVISORY The FTC has an advisory out on the domain 89biocareers.com if you are contacted by any group using a similar, but not our exact domain 89bio.com, please Report any Scams 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 for assigned regions Lead or support CRO/Vendor selection process for assigned 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 May 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 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 Travel up to 25% THE QUALIFICATIONS BA/BS in related life science field, e.g. nursing or equivalent years of experience. 8-12 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 & LEVEL 89bio considers a range of factors when determining hourly rate and level. These considerations mean actual hourly rate and level may vary. The consultant hourly range for this position based on the primary location for this position in Northern California is $80/hour to $120/hour and will be commensurate with expereince. 89bios role/level assessment approach involves assessing candidates during the interview process before confirming the level/title designation. The level assessment is considered on a case-by-case basis. Offer and level is based on factors such as: education, experience, qualifications, geographic location, transferable skills, licenses/certifications and other job-related factors permitted by law. 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. 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. All recruitment is managed through the 89bio Talent Acquisition Team. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Research and Science Industries
Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at 89bio by 2x Sign in to set job alerts for Clinical Trial Manager roles.
South San Francisco, CA $172,000.00-$191,000.00 2 weeks ago Clinical Trial Manager/Senior Clinical Trial Manager
San Francisco, CA $150,000.00-$190,000.00 19 hours ago Executive Director, Clinical Development
San Francisco Bay Area $116,000.00-$145,000.00 2 weeks ago Clinical Trial Manager/Senior Clinical Trial Manager
Sunnyvale, CA $103,000.00-$174,400.00 1 day ago San Mateo County, CA $80.00-$90.00 1 week ago Join our Talent Community- Clinical Trial Manager
Sunnyvale, CA $125,500.00-$212,400.00 1 day ago Sr. Manager, Clinical Research Scientist
Pleasanton, CA $165,000.00-$195,000.00 1 week ago San Francisco, CA $164,300.00-$399,100.00 1 day ago Associate/Sr. Associate, Life Sciences (Abingworth)
Menlo Park, CA $150,000.00-$240,000.00 1 month ago San Mateo County, CA $60.00-$70.00 3 weeks ago San Mateo County, CA $60.00-$70.00 3 weeks ago Millbrae, CA $130,000.00-$142,500.00 2 weeks ago Redwood City, CA $165,000.00-$200,000.00 2 weeks ago Sr. Clinical Trial Manager, Supira Medical
Sunnyvale, CA $103,000.00-$174,400.00 1 day ago Redwood City, CA $154,100.00-$181,300.00 1 week ago San Francisco, CA $87,000.00-$115,000.00 3 weeks ago Clinical Research Project Manager, Consultant
Alameda, CA $98,000.00-$196,000.00 1 week ago Redwood City, CA $174,700.00-$205,600.00 2 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr