Clinical Trial Manager

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Clinical Trial Manager

Reporting to the Clinical Operations Lead (COL), the Clinical Trial Manager (CTM) will be responsible for the , implementation, and oversight of AVROBIO’s clinical trials. This position will ensure efficient and timely execution throughout the lifecycle of the clinical trials in compliance with SOPs, Regulatory Authorities, and ICF/GCP guidelines.

Cambridge
Research and Development
Jun 22 2021
Key Responsibilities

45%

  • Oversees and monitors the management of the assigned clinical study, ensuring it is conducted in accordance with the approved study plans.
  • Supports the study team to execute the clinical study in accordance with the clinical development plan/strategy and timelines.
  • Manages and/or assists in the oversight of CRO activities and other clinical vendors to ensure the quality meets AVROBIO and regulatory requirements.
  • Assists in  the identification and selection of investigator sites.
  • Assists and/or participates in planning and conduct of investigator’s meetings.
  • Provides input and coordinates the delivery of clinical trial supplies in collaboration with clinical supply team.
  • Collaborates with the cross functional team on selection and potentially management of clinical vendors.
  • Oversees/assists in site activation, site training, and site management

45%

  • Coordinates with data manager to ensure query resolution, and preparation of data to meet deliverables
  • Monitors the status of clinical data collection of assigned clinical studies.
  • May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.
  • Reviews clinical monitoring reports and correspondence related to monitoring visits and reviews/addresses findings with the CRO
  • Ensures effective communication between AVROBIO and the Clinical CRO.
  • Develops and reviews study plans, and other study documents like Informed Consent Forms

5%

  • Reviews and may approves invoices
  • Oversee/assist in contracts, and change orders from CROs and other vendors.
Minimum Requirements/ Qualifications
  • Bachelor’s degree or equivalent degrees in a scientific discipline, RN, or related field.
  • 4+ years of experience working in clinical research within a pharmaceutical, biotechnology, CRO and/or healthcare setting.
  • Strong knowledge of applicable computer and project management software and tools.
  • Requires 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 interact with investigators, vendors, and internal colleagues.
  • Knowledge of current regulatory requirements and guidelines governing clinical research.
  • Ability to manage and communicate effectively with research 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
  • Performs other work-related duties as assigned
  • Available for up to 25% 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