- You will oversee the day-to-day operations of study execution, with a focus on site oversight from study startup to study closeout, patient enrollment, monitoring, compliance, and data flow and metrics from the clinical sites, CROs and vendors.
- Lead a dynamic cross-functional team to deliver clinical studies that are on time and within budget guidelines, while ensuring quality in accordance with the protocol and ICH GCP guidelines.
- Train team members and site staff, including vendors, as needed
- Participate in contract and budget negotiations with clinical sites and vendors
- Develop critical study documents including informed consent forms, study conduct documents such as study manuals, the Study Operations Manual, study tools, etc.
- Drive traceability procedures for investigational products and cross functionally coordinate patient treatment planning
- Provide oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
- Ensure reliable quality data are delivered by reviewing monitoring reports, protocol deviations, clinical data listings and performing or overseeing site monitoring visits, as needed.
- Develop action plans to address protocol compliance, safety, data and administrative issues with clinical sites and CROs.
- Assist with the onboarding and mentoring of new or junior clinical operations associates.
- BS/BA/RN Degree in science or a health-related field is preferred
- Minimum 7 years relevant industry clinical development experience, with at least 2 years of managing multi-disciplinary project teams. Sponsor experience is
- Experience and understanding of global clinical trial operations
- Pivotal clinical trial oversight, or closely relevant experience required and hematology and/or transplant experience preferred.
- Experience with all aspects of trial and site startup, CRO, vendor and laboratory management
- Familiarity with clinical data review and data management processes, including Data Monitoring Committees
- Must be able to travel up to 25%, domestically and internationally
- Creative problem-solver with excellent verbal and written communication skills
- Strong interpersonal and organizational skills, with a high degree of attention to detail.
- Ability to deal with competing priorities, strong reasoning, detail oriented and creative problem-solving ability is essential
- Ability to work on teams and with multiple projects, and works well under general direction with tight timelines and to multi-task in a fast-paced environment with changing priorities with a sense of urgency
- Excellent knowledge of GCP, ICH and FDA regulations; working knowledge of international regulations in the EU preferred
- Independently motivated to learn and lead
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Independently motivated, detail oriented and good problem-solving ability.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Positive, outgoing and collaborative attitude with a passion for helping patients using innovative science
- Be ready to embrace the principles of the Prime culture
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Senior Clinical Trial Manager - Cambridge, United States - Prime Medicine, Inc.
Description
Company Overview:
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients.
The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies.
Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.
Prime Medicine is currently progressing a diversified portfolio of eighteen programs initially focused on genetic diseases with a fast, direct path to treating patients or with a high unmet need because they cannot be treated using other gene-editing approaches.
Over time, the Company intends to maximize Prime Editing's therapeutic potential and advance potentially curative therapeutic options to patients for a broad spectrum of diseases.
For more information, please visitPosition Overview:
Join and a collaborative, agile and transformative Clinical Development Operations (CDO) team by leading and contributing to transformative clinical programs for patients in rare diseases and beyond.
Reporting to a Director of Clinical Operations, the successful candidate will be responsible for the execution of a first-in human clinical study for a novel gene therapy candidate in the Prime development portfolio.
This critical team member will effectively lead the start-up, implementation, management and expansion of clinical trial(s) in support regulatory filings.
The ideal candidate must be comfortable working independently, managing interactions with and between clinical monitors, data management, biostatistics, medical writing, safety, regulatory affairs, and pharmaceutical science and QA team members, both internally and externally.
You will ensure trial(s) are managed to the highest quality to ensure safety and effectiveness of Prime Medicine's products.Key Responsibilities:
Qualifications:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.
