Senior Clinical Data Manager

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Senior Clinical Data Manager

The Senior Clinical Data Manager will execute data deliverables for all phases of clinical trials as part of the clinical development study team. This role will proactively collaborate within cross-functional AVROBIO study teams and Contract Research Organizations and other data vendors, driving end-to-end data quality and integrity from source through to submission.

Cambridge
Research and Development
May 26 2021
Key Responsibilities
  • Lead Clinical Data Management for the assigned complex studies from study start-up to the database lock. Function as internal Study Data Manager, overseeing all data management activities performed by CROs; ensuring major DM deliverables and milestones are met
  • Oversee clinical database build by the vendors, facilitate database design according to the protocol, perform and facilitate clinical database User Acceptance Testing.
  • Oversee external data transfers, review, cleaning and medical coding by vendors by tracking of study metrics and targeted data review.
  • Participate in the Clinical Data Management vendor selection and oversight at the study level
  • Ensure compliance with the CDM SOPs at the study level
  • Create specifications for internal study team data review plans. Lead internal study team in data review; perform data review for quality issues and general data trends; generate queries as necessary.
  • Represent Clinical Data Management at study team meetings, provide agenda items and follow-up on action items through resolution. Serves as a Study DM liaison with cross-functional team members and external vendors to ensure completion of all timelines and study-related tasks
  • Assist Quality Assurance and the Clinical Study Teams as needed with inspection readiness activities
  • Reviews and manages key CDM study documents such as data management plans, guidelines for CRF completion, data review, SAE reconciliation, Vendor Oversight, TMF plans, and data audits. Ensure Clinical Data Management Study Documentation is up to date and filed as appropriate
Minimum Requirements/ Qualifications
  • Minimum 6 years of relevant Clinical Data Management experience
  • Minimum – BS degree in a Data Science or equivalent.
  • Knowledge of current FDA Regulations, GCP and ICH guidelines in clinical trials
  • Proficient written and verbal communication skills
  • Ability to collaborate effectively with the study team, cross-functional team members
  • Vendor oversight experience
  • Ability to work independently as well as within a cross-functional team environment
  • Strong computer skills including Medidata Rave and other EDC systems
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