Data Project Manager

bucharest, , Romania
Closing date
10 Oct 2020

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Data Management / Statistics, Clinical Data Management
Full Time
Contract Type
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Job Overview:
Joining Covance Flexible Solutions (FSPx) will offer a rewarding career, a chance to work in an energetic & team-oriented workplace, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you'll be empowered to own your career journey with mentoring, training and personalized development planning.

Our unique opportunity will allow you to bring your specialized discipline to a core team outsourced to a world class leading global healthcare company. Dedicated to our Client 100% of the time, you will play a key role in the drug development cycle and see a product through to launch with the support of both a dedicated Covance line manager and our client project teams.

Your role:

The Data Project Manager role is a great opportunity to work within our sponsor dedicated department and have this unique relationship with a sponsor.
  • Collaborate with respective project sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing.
  • Effectively plan and execute multiple Data Management projects simultaneously
  • Assign tasks and responsibilities within Data Management to team members, in a manner that: optimizes team capability; delivers timely and accurate results; and supports the needs of the business
  • Ensure that assigned team executes Data Management functions in accordance with Chiltern and/or sponsor Standard Operating Procedures (SOPs)
  • Serve as Data Management Lead on selected projects
  • Create study specific Data Management Plans (DMPs)
  • Provide input, assistance and/or oversight with preparation of edit check specifications for a specific project, Data entry guidelines preparation, Case Report Form design and associated specification
  • Oversee and contribute to creation of test data for entry screens and edit checks
  • Serve as primary contact for DM with all relevant parties including but not limited to Clinical Operations and Sponsor, informing stakeholders if there is a need to deviate from project scope or plan
  • Manage sponsor relationships and triage issues as appropriate
  • Ensure that project team member performance supports project budget and delivery requirements
  • Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections
  • Participate/attend Sponsor requested meetings as required
  • Perform other duties as required by the Department
  • Education/Qualifications:

    • University degree in Medical/Life Science/Computer Science

    • • Ability to maintain confidentiality of data and information during interactions with staff at all levels

      • Prior experience in Data Management in the pharmaceutical, biotechnology, medical device/diagnostics or clinical trial industries.

      • Effective communication skills

      • Working experience with Medidata Rave, Inform and Oracle Clinical is preferred

      • Strong leadership qualities and experience of supervising other Data Managers

      • Hands on experience with EDC systems

      • Good knowledge of the drug development life cycle

      • Understanding of the principles of ICH GCP and regulatory requirements

      • Good computer literacy with working knowledge of Windows and Microsoft Office applications

      • Good oral and written communication, organisational skills and personal presentation

      • The ability to communicate effectively in English

      • Experience working within a team environment under time and resource pressures

      • Proven experience in clinical trials with knowledge of SOPs, regulatory reporting requirements and accepted practices

      • Confident dealing with external and internal clients and providers

    Covance Profile Page image

    Join our growing team and discover your extraordinary potential

    We are recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our 20,000+ team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, our comprehensive service portfolio provides the opportunity to explore diverse projects and unique career paths across the drug development spectrum.

    Please visit our Careers Hub

    Learn more about our work to improve health and improve lives:

    Contact Us
    • Maidenhead Office Park
    • Westacott Way
    • Maidenhead
    • SL6 3QH
    • United Kingdom
    • Mini-site: Covance
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