Clinical Trial Manager, Sample Logistics and Operations

Company: Adicet Bio, Inc.
Location: Redwood City
Posted on: January 23, 2023

Job Description:

JOIN US! Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs) and adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for durable activity in patients. For more information, please visit our website at . CLINICAL TRIAL MANAGER, SAMPLE LOGISTICS AND OPERATIONS A Clinical Trial Manager, Sample Logistics and Operations position will work closely with clinical operations and translational medicine teams to implement all aspects of clinical biomarker plans to support multiple clinical programs. The position will liaise with clinical sites, central labs, biomarker labs and internal stakeholders to ensure successful sample management execution across Adicet's clinical programs. Key responsibilities:

• Responsible for biospecimen sample routing, tracking, and query resolutions between clinical sites and the central lab and CROs.
• Responsible for planning, coordinating, and tracking biospecimen shipments (PK, biomarkers) between central lab and specialty vendors.
• Responsible for oversight of long-term biospecimen management.
• Assist in drafting and reviewing clinical study protocols for sample collection requirements and alignment with the SOW (PK, biomarkers), study lab manuals, and relevant company policies.
• Assist in ensuring the availability of clinical trial supplies related to biospecimen collection, processing, shipment, and storage.
• Work cross-functionally to assist in implementing regulatory and compliance efforts regarding the collection and analysis of clinical samples, including HIPAA requirements, privacy policies, and chain of custody.
• Assist in tracking informed consents for clinical sample use (incl. future & unrelated research); may also contribute to the review of consent form language for consistency across protocols and alignment with sample storage and retention policies.
• Assist in other aspects of analysis vendor management, including contracts, data transfer agreements, and data handling.
• Assist in generating sample and data flow charts for clinical studies Qualifications:
  • BS with 5+ years' experience in pharmaceutical or biotech industry
  • Experience managing central labs, biomarker labs and operations
  • Solid understanding of cGMPs, clinical operations, and drug development processes
  • Detailed oriented with ability to work in a fast-changing environment
  • Strong analytical, problem solving, and communication skills.
  • Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams. Adicet Bio requires all workers to be fully vaccinated against COVID-19, including the booster dose. 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 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 12 company holidays with end-of-year shutdown, 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, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms. In compliance with California's pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $124,000 - $171,000 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Keywords: Adicet Bio, Inc., Redwood City , Clinical Trial Manager, Sample Logistics and Operations, Professions , Redwood City, California