- 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.
- Present at Investigator Meetings.
- Maintain website information per SOP.
- Travel up to 25%.
- BA/BS in related life science field, e.g. nursing or equivalent years of experience.
- 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.
- Excellent computer skills.
- Advanced degree desired.
- Experience with Phase 1 trials is preferred.
- Competitive health insurance coverage
- Generous PTO allowance
- 401k match
- Employee Stock Purchase Plan (ESPP)
- Commuter Benefits
- 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
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Clinical Trial Manager/Senior Clinical Trial Manager - San Francisco, United States - 89bio
Description
THE 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.
SPECIAL ADVISORY
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THE RESPONSIBILITIES
THE QUALIFICATIONS
SALARY & LEVEL
89bio considers a range of factors when determining the salary and level. These considerations mean actual salary and level may vary. The salary range for this position is $135,000 - $185,000 and will be commensurate with experience.
THE PERKS
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. All recruitment is managed through the 89bio Talent Acquisition Team.
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