Clinical Trial Manager

Adicet Bio • Redwood City, CA

2d • Hybrid

About The Position

As a Clinical Trial Manager, you will be responsible for the operational planning, execution, oversight, and delivery for assigned clinical trials. The Clinical Trial Manager will ensure studies are conducted in compliance with GCP/ICH, company Standard Operating Procedures (SOPs), study timelines, and budget. You 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
• Experience with managing studies in electronic data capture systems
• Experience with project, vendor, contract, and clinical research staff management
• Experience with Institutional Review Board (IRB) preparations and submission
• Ability to work independently, collaboratively and manage deadlines

Nice To Haves

• Knowledge in molecular diagnostics or laboratory skills is a plus

Responsibilities

• Work closely with the Clinical Operations team to support all aspects of global clinical studies
• Take a leadership role in certain site and study management activities including: ICFs, site activations, monitoring reports and study plan review and creation
• Leading and presenting at Study Execution Team meetings
• 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 as needed to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits
• Generate and maintain reports, listings, and trackers as needed
• Ensure close tracking of site enrollment and related metrics
• Establish and maintain clinical trial master files (TMF)

Benefits

• Competitive compensation package
• Base salary
• 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 insurance
• AD&D insurance
• Short-term disability insurance
• Long-term disability insurance
• Legal insurance
• Pet insurance
• Various other voluntary insurance programs
• Generous paid time-off
• 13 company holidays
• Paid end-of-year winter break
• Vacation time
• Sick time
• Paid parental leave
• Onsite gym
• Various other fitness options
• Onsite parking with electric vehicle charging stations
• Free shuttle (Caltrain)
• Company-subsidized lunches
• Fully stocked breakrooms

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level