Reporting to the Clinical Operations Lead (COL) the Clinical Trial Manager (CTM) will be responsible for the planning, 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.
- Oversees and monitors the management of the 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.
- Leads/assists in oversight of 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.
- 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.
- Ensures effective communication between AVROBIO and the Clinical CRO.
- Develops and reviews study plans including the clinical review of Case Report Forms (electronic as applicable), data review plan, and other data management documents and corresponding completion guidelines.
- May generate or assist in critically evaluating proposals, contracts, and change orders from CROs and other vendors.
- Bachelor’s degree or equivalent degrees in a scientific dicipline, RN, or related field.
- Two plus (2+) 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 invesigators, vendors, and internal colleages.
- 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
Other Job Requirements:
- Available for up to 25% domestic and/or international travel.
To apply, email your resume to: firstname.lastname@example.org
AVROBIO, Inc is an EEO employer
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