Clinical Trial Manager
NGM Biopharmaceuticals, Inc. is a biopharmaceutical company dedicated to discovering and developing the next generation of medicines for the treatment of serious diseases. Our experienced scientific team has joined forces with an impressive group of industry professionals, Nobel Laureates and other distinguished researchers to build a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine that has a track record of generating one new IND candidate per year. NGM’s current pipeline of clinical-stage programs consists of five drug candidates targeting liver and metabolic diseases, retinal diseases and cancer. The most advanced drug candidate, aldafermin (NGM282), is in Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH) and is wholly-owned by NGM. Another drug candidate, NGM621, is in a Phase 2 study in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). NGM’s strategic collaboration with Merck, with a current term running to March 2022, provides us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.
The Clinical Ops group is seeking a Clinical Trial Manager to join a high-performance team. The Clinical Trial Manager will be accountable for the day-to-day operational oversight of one or more clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity typically is coordinated in conjunction with one or more CROs. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
- Manage the operational aspects of clinical trials
- Participate in protocol, CRF development, Clinical Study Report preparation, as appropriate
- Prepare metrics and updates for management, as assigned
- Proactively identify potential study issues/risks and recommends/implements solutions
- Participate in and facilitate CRO/vendor selection process for outsourced activities
- Manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
- May work with CRO to develop and revise the scope of service agreements, budgets, plans, and detailed timelines, and ensure that performance expectations are met
- Prepare and/or review/approve study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
- Manage clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
- Manage set-up and testing of electronic data management system at CRO
- Manage set-up and testing of IWRS system at CRO
- Recommend and implement innovative process ideas to impact clinical trials management
- Organize and manage internal team meetings, investigator meetings, and other trial-specific meetings
- Serve as a liaison and resource for investigational sites
- Review site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
- BA/BS or equivalent degree in scientific discipline.
- Minimum 5 years of clinical trial management experience in biotech
- Experience in managing outside vendors, e.g., CROs and other vendors
- Experience with U.S. and Ex-U.S clinical trial management and Regulatory processes
- Experience in one of our core disease states (liver, metabolic, ophthalmic, and cancer)
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, 401(k) and a comprehensive benefits package.
Interested applicants should click "Apply"
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