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Senior Quality Analyst, Database Development & Validation

Company: Biogen
Location: Cambridge
Posted on: January 12, 2022

Job Description:

Company Description

At Biogen, we offer a workplace that is unique, connected, resilient and impactful. Our purpose to find cures for rare diseases is a unique focus within our industry. We are connected as a team by this shared purpose, the pride we have in our work, and the inspiration we obtain from the lives we're changing. We are resilient as we overcome obstacles, following the science to deliver for our patients. Most of all, our work allows us to have an impact. An impact on our patients' lives and on changing the course of medicine.

About This Role

Job Description

As the Senior Quality Analyst, Database Development & Validation, you are responsible for the assessment and tracking of the quality of clinical data, data cleaning, and submission activities executed by Biogen staff, CROs, and Functional Service Providers performing clinical trial work for Biogen. You contribute to the development and maintenance of processes, tools, best practices, and metrics relating to tracking and analyzing quality of clinical data, data cleaning, and submission activities within ADS. You collaborate with the ADS staff, management, vendor data managers, data standards and quality teams to schedule and conduct the review of study documentation, data quality, programming, and submission activities. You ensure that all clinical trial data, data cleaning, programming and submission activities are consistent with the needs of the study protocol and department standards and procedures. You will collaborate closely with ADS Data and Analytics Leads to plan timelines and workload to ensure deliverables are met across the Biogen portfolio.

What You'll Do

  • Plan and conduct clinical data quality review tasks for all Biogen projects, managing multiple competing timelines and priorities
  • Perform validation activities related to UAT of EDC setup, Integrations, post production changes and Reports programming.
  • Perform eCOA UAT Dry Run.
  • Perform Script writing and script execution on IT related tasks for product validation using HP ALM.
  • Perform Quality Review activities such as Audit Trial Review, Query Quality Review, User Access Management.
  • Review validation documents and ensure timely upload of approved documents to TMF. Monitor quality metrics on tasks related to validation of Databases and Reports.
  • Conduct peer review of data cleaning processes, programming and submission activities from internal and vendor employees, providing analysis and trending of quality to management and feedback and training to internal and vendor employees as needed.
  • Review CAPAs of deliverables and contribute to the development and maintenance of processes, tools, best practices, and metrics for tracking and analyzing the quality of clinical data, data cleaning, and submission activities within ADS Operations Support.
    Who You Are

    You are highly proactive, work collaboratively with other groups, have strong attention to detail along with written, verbal and listening skills, presentation skills, teaming, facilitation and relationship building skills. You have a demonstrated understanding of the business and strong organizational skills.

    Qualifications

    Required skills:
    • Bachelor's degree required, in Biology / Chemistry, Life Sciences, Clinical Data Management, or Drug Development preferred
    • At minimum, 5 years of R&D drug development experience in-house at a pharmaceutical firm.
    • Demonstrated strength in managing multiple projects and/or programs (i.e., collection of sub-projects) and business analysis.
    • Knowledge of EDC systems, Data management reports/listings, GCP and other regulations.
    • Internal customer management, influence of peers, team effectiveness and enhancement, timeline management, proactive problem solving ability, ability to develop trust, shared goals and values.
    • Collaborative, with negotiation skills, conceptual thinking, systems process thinking, accountability to deliverables milestones, conflict resolution (internal and external).
    • Must have excellent oral and written communication / presentation / negotiation skills.
    • Detail oriented, able to identify issues and consistently collaborate to solve problems in a timely manner.
    • Ability to handle multiple (changing) priorities under tight timelines
    • Fluent with technology solutions to manage projects including appropriate Microsoft Office programs (i.e., Word, Excel, PowerPoint, Project, Visio) and also SharePoint
      Additional Information

      Why Biogen?

      Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

      All your information will be kept confidential according to EEO guidelines.

Keywords: Biogen, Cambridge , Senior Quality Analyst, Database Development & Validation, Professions , Cambridge, Massachusetts

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