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Clinical Trial Manager (Contract)

Company: bluebird bio
Location: Cambridge
Posted on: January 15, 2022

Job Description:

About The Nest

At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We're 500+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.

Clinical Trial Manager (Contract)

This role is for a 12-month contract position.

About The Flock

The Clinical Development Operations flock is all about getting stuff done while working enthusiastically and collaboratively. As a member of the Clinical Development Operations (CDO) department, the successful candidate will be responsible for overseeing all aspects of clinical study management for a gene therapy product in development. Responsibilities include study planning and global execution, timelines, budget, clinical site and vendor management. You will also be responsible for the preparation of study related materials, relationship management between clinical sites/vendors/KOLs, and identification of project risks and contingency planning. The ideal candidate must be comfortable working independently, managing interactions with experienced clinical monitors, and cross-functional internal/external project stakeholders (e.g., medical, data management, biostatistics, safety, regulatory affairs, medical affairs, and pharmaceutical science and QA/QC team members.

How You'll Fly

As a Clinical Trial Manager bird, you'll help to bring more patients their bluebird days by:

  • Integral member of Clinical Team leading at least 1 global clinical study
  • Lead cross-functional internal/external study management meetings
  • Provide oversight of study vendors and consultants
  • Develop critical study documents including project plan, monitoring plan, study operations manual, model informed consent form, etc.
  • Manage and communicate overall study plans including timelines, internal and external resources/costs and budgets/invoices, as well as critical deliverables.
  • Execute on data deliverables (e.g., IB, DSUR) in support of ongoing studies
  • Train team members and site staff, including vendors, as needed
  • May perform clinical site activities, such as on-site monitoring, co-monitoring, training, and motivational visits, as needed
  • Review and approve corrective action plans at clinical sites and vendors, active participant in internal/external study related audits and inspections
  • Active engagement of KOLs, Study Investigators and staff, frequent communication with Medical Monitor
  • Overcome challenges associated with cultural differences on a global study
  • Work independently, escalate issues and reach out for support when needed
  • Other related tasks as needed

    What You'll Bring

    You're the bird we're looking for if you:
    • Bachelor's Degree in science or health-related discipline, advanced degree preferred
    • 3-5 years relevant industry/CRO clinical development experience, with at least 2 years of managing cross-functional project teams
    • Experience and understanding of global clinical study operations in rare diseases, pediatrics, and/or bone marrow transplant experience welcome
    • Experience with all aspects of study and site startup and vendor management
    • Excellent knowledge of GCP, ICH and FDA regulations
    • Experience with BLA submissions, regulatory agency inspections is a plus
    • Familiarity with clinical data review and data management processes, including Data Monitoring Committees
    • Ability to travel up to 10%, domestically and internationally (not mandatory)
    • Strong verbal and written communication skills
    • Ability to deal with competing priorities, strong reasoning, detail oriented and creative problem-solving ability is essential
    • Ability to work on teams with aggressive timelines and to multi-task in an extremely fast-paced and dynamic environment with changing priorities
    • Independently motivated to learn and lead with minimal direction needed
    • "Do-what-it-takes" approach to problem solving and prospective thinking
    • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

      All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.

      bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.

      bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

Keywords: bluebird bio, Cambridge , Clinical Trial Manager (Contract), Healthcare , Cambridge, Massachusetts

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