Clinical Trial Manager

Adicet Bio•Redwood City, CA

1d•Hybrid

About The Position

The Clinical Trial Manager is responsible for operational planning, execution, oversight, and delivery of assigned clinical trials. The role ensures studies comply with GCP/ICH, company Standard Operating Procedures (SOPs), study timelines, and budgets. The manager works cross-functionally with Adicet Bio teams and with study sites, CROs, and other vendors. Employees are required to work onsite at least three days per week, Tuesday through Thursday; some roles require full-time onsite presence.

Requirements

BS or higher degree in science, nursing (RN or BSN), or an equivalent discipline.
At least 4 years of clinical research experience in the biotechnology, pharmaceutical, or CRO industry.
Experience supporting studies in a fast-paced environment.
Success working with CROs and vendors.
Excellent communication skills and ability to achieve milestones in a team environment.
Strong working knowledge of FDA requirements, ICH Guidelines, and GCPs governing clinical trials.
Experience 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 submissions.
Ability to work independently and collaboratively and manage deadlines.

Nice To Haves

Knowledge of molecular diagnostics or laboratory skills.

Responsibilities

Work with the Clinical Operations team to support all aspects of global clinical studies.
Lead selected site and study management activities, including informed consent forms (ICFs), site activations, monitoring reports, and study plan review and creation.
Lead and present at Study Execution Team meetings.
Collaborate with cross-functional team members to independently address routine study issues.
Assist with CRO and vendor oversight and management to ensure milestones are achieved.
Identify issues for escalation, participate in problem solving, and implement risk mitigation.
Participate in departmental and corporate initiatives.
Perform co-monitoring visits as needed for site qualification, site initiation, routine monitoring, and close-out visits.
Generate and maintain reports, listings, and trackers as needed.
Closely track site enrollment and related metrics.
Establish and manage clinical trial master files (TMF).

Benefits

Competitive compensation package including base salary, annual cash bonus, and long-term equity incentives.
Employee Stock Purchase Plan (ESPP).
401(k) with Roth option and a 4.5% company match.
Medical, dental, and vision health plans.
Flexible Health and Commuter Spending Accounts (FSA) and a company-matched Health Savings Account (HSA).
Life, AD&D, short-term disability, and long-term disability insurance.
Legal, pet, and other voluntary insurance programs.
Paid time off, including 13 company holidays, a paid end-of-year winter break, vacation, sick time, and paid parental leave.
Onsite gym and other fitness options.
Onsite parking with electric vehicle charging stations and a free Caltrain shuttle.
Company-subsidized lunches delivered onsite daily and fully stocked breakrooms.