Clinical Project Manager

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.

Clinical Project Manager

The 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.

Remote
Research and Development
Nov 1 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
  • 6+ 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
About AVROBIO

Our vision is to bring personalized gene therapy to the world. We aim to prevent, halt or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our ex vivo lentiviral gene therapy pipeline includes clinical programs in Fabry disease, Gaucher disease type 1 and cystinosis, as well as preclinical programs in Hunter syndrome, Gaucher disease type 3 and Pompe disease. AVROBIO is powered by our industry leading plato® gene therapy platform, our foundation designed to deliver gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario.

AVROBIO, Inc is an EEO employer