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Sr. Manager, Clinical Quality

Company: TCR Therapeutics
Location: Cambridge
Posted on: June 22, 2022

Job Description:

At TCR Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage -cell therapy -company pioneering the development of novel T cell therapies -by utilizing our TRuC platform. Our lead -autologous -cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for -treatment refractory mesothelin-expressing -solid tumors. In addition, -our -emerging and dynamic oncology pipeline -focuses on -a series of next-generation enhancements, -novel targets and an allogeneic platform which -may further improve clinical outcomes -and broaden patient access.We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD. -This role will be based in Cambridge, MA.We are looking for an enthusiastic, motivated Senior -Manager, Clinical Quality to provide oversight to the GCP systems and compliance of our clinical studies. You will report to our Director, Research & Clinical Quality and work closely with groups throughout the organization to ensure compliance with regulatory requirements and to support clinical initiatives. The individual in this role will be responsible for providing Quality support to the external and internal functions to ensure robust processes and systems are implemented to support the clinical programs. If you thrive in a highly collaborative, fast-paced environment and are looking for a role where youre given ownership and accountability to get results and make an impact, come grow your career with us.Responsibilities:

  • Serve as subject matter expert for GCP regulations and requirements
  • Provide guidance to CRO to ensure study issues are addressed and resolved
  • Manage the quality aspects of all cross functional areas involved in the clinical studies
  • Liaise with clinical functions and external parties including CROs, vendors, and investigator sites to promote a high level of quality and consistency across and within programs
  • Support Clinical trial managers/Directors with clinical trial activities
  • Identify noncompliance trends and systematic risks for assigned areas of responsibility
  • Participate with the development and implementation of procedures, processes, etc.for the GCP program
  • Review and approve essential monitoring documents and plans
  • Review outcomes/actions related to protocol deviations; identifying trends across investigator sites or the study
  • Document review and monitoring risks and decisions at the study level and implementation of mitigation strategies
  • Participate in clinical document reviews including regulatory submissions, study report, protocols, and SOPs
  • Generate and report quality metrics of compliance activities at management review
  • Work collaboratively with Data managers and internal functional teams to ensure that data management functions are performed in compliance with regulations and study protocol and procedures
  • Support regulatory authority inspections as required
  • Demonstrate strong proficiency in the application of the CAPA system to ensure actions, verification and closure of effectiveness of solutions applied to root cause issues originating from CROs audits or other sources.Requirements:
    • Bachelors degree in the biological sciences or related field.
    • 8+ years of clinical monitoring or quality assurance experience in the pharmaceutical/biotechnology field
    • Understanding/working knowledge with ICH and GCP guidelines
    • Process-oriented, with the ability to demonstrate good judgment and decision-making
    • Exceptional organizational skills and ability to deal with competing priorities
    • Experience with Protocol, ICF, CRF, CSR development and review
    • Strong technical writing skills, specifically with effective report, investigation documents experience
    • Excellent communication, collaboration, partnering, and influencing skills requiredPowered by JazzHR

Keywords: TCR Therapeutics, Cambridge , Sr. Manager, Clinical Quality, Executive , Cambridge, Massachusetts

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