BioSpace
Overview
SR. CLINICAL TRIAL MANAGER at Adicet Bio, Inc. is a clinical operations role focused on supporting all aspects of Adicet Bio’s clinical trials, including site activation, patient recruitment, study monitoring, site and CRO/vendor management. The successful candidate will have experience managing oncology clinical trials and a solid knowledge of clinical operations, ICH/GCP and FDA regulatory requirements, and will work cross-functionally with study sites, CROs and other vendors. Key Responsibilities
Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a complex environment in accordance with quality and GCP standards with minimal oversight Lead the identification, evaluation, selection, and oversight of clinical trial sites, vendors and CROs Work closely with the Clinical Operations team to support all aspects of clinical studies Manage multiple clinical study vendors with oversight of activities Plan and conduct Investigator’s meetings Take a leadership role in site and study management activities including ICFs, site activations, monitoring reports and study plans Collaborate with cross-functional team members to independently address routine study issues Assist with CRO and/or vendor oversight and management to ensure milestones are achieved Identify issues for escalation, participate in problem solving and implementation of risk mitigation Participate in departmental and corporate initiatives Perform co-monitoring visits with CRO, as needed, to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits Ensure data entry is up to date and site queries are resolved in a timely manner Assist with department compliance initiatives and SOP writing Generate and maintain reports, study trackers, internal and external presentations and study documents as needed Ensure close tracking of site enrollment and related metrics Establish and manage clinical trial master files (TMF) Complete other responsibilities as assigned Qualifications
BS or higher degree in science, nursing (RN or BSN), or equivalent discipline A minimum of 6 years of clinical research experience in biotechnology, pharmaceutical, or CRO industry Experience supporting studies in a fast-paced environment Success in working with CROs and vendors Excellent communication skills and ability to achieve milestones in a team environment Strong working knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials Proficiency with Microsoft Word, Excel, PowerPoint and Project Adicet Bio requires all workers to be fully vaccinated against COVID-19, including the booster dose Compensation and Work Arrangement
Pay Range: $161,000—$223,000 USD In-person onsite requirement: Employees are required to be onsite at least three days per week (Tuesday–Thursday mandatory), with some roles requiring full-time onsite presence. We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with Roth and a 4.5% company match. Comprehensive health plans (medical, dental, vision), Flexible Health and Commuter Spending Accounts (FSA), company-matched Health Savings Account (HSA), life, AD&D, disability insurance, legal and other voluntary programs. Generous paid time off including 13 company holidays, winter break, vacation, sick time, and paid parental leave. Onsite facilities include gym, parking with EV charging, free shuttle, and subsidized lunches. Adicet is committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Additional Information
Seniority level: Mid-Senior level Employment type: Full-time
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SR. CLINICAL TRIAL MANAGER at Adicet Bio, Inc. is a clinical operations role focused on supporting all aspects of Adicet Bio’s clinical trials, including site activation, patient recruitment, study monitoring, site and CRO/vendor management. The successful candidate will have experience managing oncology clinical trials and a solid knowledge of clinical operations, ICH/GCP and FDA regulatory requirements, and will work cross-functionally with study sites, CROs and other vendors. Key Responsibilities
Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a complex environment in accordance with quality and GCP standards with minimal oversight Lead the identification, evaluation, selection, and oversight of clinical trial sites, vendors and CROs Work closely with the Clinical Operations team to support all aspects of clinical studies Manage multiple clinical study vendors with oversight of activities Plan and conduct Investigator’s meetings Take a leadership role in site and study management activities including ICFs, site activations, monitoring reports and study plans Collaborate with cross-functional team members to independently address routine study issues Assist with CRO and/or vendor oversight and management to ensure milestones are achieved Identify issues for escalation, participate in problem solving and implementation of risk mitigation Participate in departmental and corporate initiatives Perform co-monitoring visits with CRO, as needed, to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits Ensure data entry is up to date and site queries are resolved in a timely manner Assist with department compliance initiatives and SOP writing Generate and maintain reports, study trackers, internal and external presentations and study documents as needed Ensure close tracking of site enrollment and related metrics Establish and manage clinical trial master files (TMF) Complete other responsibilities as assigned Qualifications
BS or higher degree in science, nursing (RN or BSN), or equivalent discipline A minimum of 6 years of clinical research experience in biotechnology, pharmaceutical, or CRO industry Experience supporting studies in a fast-paced environment Success in working with CROs and vendors Excellent communication skills and ability to achieve milestones in a team environment Strong working knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials Proficiency with Microsoft Word, Excel, PowerPoint and Project Adicet Bio requires all workers to be fully vaccinated against COVID-19, including the booster dose Compensation and Work Arrangement
Pay Range: $161,000—$223,000 USD In-person onsite requirement: Employees are required to be onsite at least three days per week (Tuesday–Thursday mandatory), with some roles requiring full-time onsite presence. We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with Roth and a 4.5% company match. Comprehensive health plans (medical, dental, vision), Flexible Health and Commuter Spending Accounts (FSA), company-matched Health Savings Account (HSA), life, AD&D, disability insurance, legal and other voluntary programs. Generous paid time off including 13 company holidays, winter break, vacation, sick time, and paid parental leave. Onsite facilities include gym, parking with EV charging, free shuttle, and subsidized lunches. Adicet is committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Additional Information
Seniority level: Mid-Senior level Employment type: Full-time
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