Onsite Clinical Trial Manager - Biotech Growth

BioSpace; Redwood City (CA); On-site; USD 131,000 - 181,000; Full time

Benefits offered by this job

Onsite gym

401(k) match

Paid time off

Job summary

Adicet Bio, Inc. is a clinical stage biotechnology company discovering allogeneic gamma delta T cell therapies for autoimmune diseases and cancer.

The Clinical Trial Manager will oversee operational planning, execution, and delivery for global trials, ensuring compliance with GCP/ICH and SOPs. Role requires onsite presence three days per week and collaboration with CROs, sites, and cross-functional teams to meet milestones.

Qualifications

• BS or higher degree in science, nursing (RN or BSN), or equivalent discipline.
• Minimum 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.

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 manage clinical trial master files (TMF).

Skills

Clinical trial management

FDA/ICH/GCP knowledge

Vendor management

Cross-functional collaboration

Monitoring visits

Study planning

Education

BS or higher in science or nursing

Tools

EDC systems

TMF management

IRB submissions

Job description

Adicet Bio, Inc. is a clinical stage biotechnology company discovering allogeneic gamma delta T cell therapies for autoimmune diseases and cancer.

The Clinical Trial Manager will oversee operational planning, execution, and delivery for global trials, ensuring compliance with GCP/ICH and SOPs. Role requires onsite presence three days per week and collaboration with CROs, sites, and cross-functional teams to meet milestones.