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clinical trial manager

3 weeks ago

Redwood City, California, United States Adicet Bio Full time

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

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.

Key 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

Qualifications:

  • 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

Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite at least three days per week (Tuesday–Thursday mandatory), with some roles requiring full-time onsite presence.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting autoimmune diseases and cancer.

We offer a 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.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an 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.

Adicet is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.