Clinical Trial Manager

Adicet Bio•Redwood City, CA

18h•Hybrid

About The Position

JOIN US! Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com . CLINICAL TRIAL MANAGER As a key member of the clinical operations team, this position will support 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 good knowledge of clinical operations, ICH/GCP and FDA regulatory requirements and will work cross functionally within the Adicet Bio team as well as with study sites, CROs and other vendors.

Requirements

BS or higher degree in science, nursing (RN or BSN), or equivalent discipline
A minimum of 4 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

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 certain 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, on an as needed basis, to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits
Ensuring 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

Benefits

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, etc.)
Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA)
life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs
generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave
onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms

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