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Adicet Bio, Inc · 1 day ago

CLINICAL TRIAL MANAGER

Redwood City, CA

Full-time

Onsite

Mid, Senior Level

$131K/yr - $181K/yr

4+ years exp

Adicet Bio, Inc. is a clinical stage biotechnology company focused on developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The Clinical Trial Manager will support all aspects of clinical trials, including site activation, patient recruitment, and study monitoring, while ensuring compliance with regulatory standards.

BiopharmaBiotechnologyHealth CareMedical

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

Qualification

Clinical research experienceOncology clinical trialsFDA regulatory knowledgeICH/GCP knowledgeCRO/vendor managementMicrosoft Office proficiencyCommunication skillsTeam collaboration

Required

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

Benefits

Annual cash bonus

Long-term incentives (equity)

Employee Stock Purchase Plan (ESPP)

401(k) with ROTH and a 4.5% Company match

Comprehensive health plans (medical, dental, vision, etc.)

Flexible Health and Commuter Spending Accounts (FSA)

Company matched Health Savings Account (HSA)

Life, AD&D, short and long-term disability insurance

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

Paid parental leave

Onsite gym and various other fitness options

Onsite parking with electric vehicle charging stations

Free shuttle (Caltrain)

Company-subsidized lunches (delivered onsite daily)

Fully stocked breakrooms

Company

Adicet Bio, Inc

At Adicet (Nasdaq: ACET), we are defined by our mission to deliver best-in-class gamma-delta T cell therapies for patients fighting autoimmune diseases and cancer.

Founded in 2014

Redwood City, California, USA

51-200 employees