Sr. Clinical Project Manager

Company: AVROBIO
Location: Cambridge
Posted on: February 18, 2021

Job Description:

Our culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life. Sr. Clinical Project Manager The Sr. Clinical Project Manager is the leader of the Clinical Study Team and will lead the planning and delivery of AVROBIO study(ies) to time, budget, and quality according to the Clinical Development Plan (CDP), Good Clinical Practice (GCP), local regulations, guidelines, and SOPs. Cambridge Research and Development Feb 8 2021 Key Responsibilities 45%

• Oversee and lead the cross-functional study team in the successful execution of the assigned clinical study(ies)
• Partner with Manufacturing and Clinical Supply to provide--investigational product (IP)--assumptions and--forecasting and collaborate cross-functionally to monitor IP preparation and testing for release
• Contribute to study protocol development including study concept,--where applicable
• Develop,--manage,--and oversee--study timelines,--metrics,--and quality standards [ICH/GCP/SOPs]--in collaboration with all--study team members/functions
• Drive assessment, selection, management,--and oversight--of clinical study vendors, including CROs
• Develop, manage, and track the trial budget--and provide ongoing financial reporting and forecasting
• Author, review, and approve study documents, plans, and manuals--and ensure execution of activities outlined in study plans 45%
  • Lead and contribute to study feasibility activities
  • Lead site identification and selection activities
  • Participate in ongoing data reviews
  • Lead, plan,--and execute clinical Investigator meetings, study meetings,--and other clinical vendor meetings--Reviews clinical monitoring reports and correspondence related to monitoring visits.
  • Ensure that the Trial Master File (TMF) is set up and maintained--throughout the--duration of the clinical study
  • Cultivate relationships and ensure effective communication between the clinical study team and external stakeholders (e.g., sites, PIs, KOLs, and vendors).
  • Ensure--study--risks are proactively identified, managed, and mitigation strategies are implemented 10%
    • May participate in site and vendor audits
    • May perform periodic visits to sites and/or vendors to assess progress of studies/protocol compliance
    • Participate in Clinical Operations initiatives, including the development and review of Quality Documents Minimum Requirements/ Qualifications
      • Bachelor's degree or equivalent degrees in a scientific discipline, RN, or related field
      • 10+ years of experience working in clinical research within a pharmaceutical, biotechnology,--or--CRO--with at least 2 years in study/project management
      • Successful execution of global clinical trials--(Phase I-Phase III)--and investigator-initiated studies
      • Experience in--leading--rare disease and/or gene therapy--clinical--studies
      • Experience managing and overseeing CROs and multiple clinical vendors
      • Experience in study start-up--Strong knowledge of applicable computer and project management software and tools
      • Excellent team management abilities with a comfort level working with senior management
      • Strong attention to detail and the ability to establish priorities, schedule, and meet deadlines
      • Ability to work successfully within a cross-functional team and a matrix organization
      • Excellent written and oral communication skills
      • Ability to--establish--and foster--effective relationships--with investigators, vendors, and internal colleagues--that support and advance trial team goals and objectives
      • Knowledge of current regulatory requirements and guidelines governing clinical research
      • Ability to manage and communicate effectively with--clinical--vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints
      • Must be able to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands
      • Ability to complete tasks to deadlines and resolve/elevate problems in a timely manner under limited direction and on own initiative
      • Available for up to 10% domestic and/or international travel AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients' lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR-RD-01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO's lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

Keywords: AVROBIO, Cambridge , Sr. Clinical Project Manager, Healthcare , Cambridge, Massachusetts