PRAHS

  • Principal Lead Data Manager

    Job Locations (All) | Canada-NT
    Posted Date 5 days ago(1/14/2019 11:15 AM)
    ID
    2019-51456
  • Overview

    Who we are:

    • Over 470 PRA Biometrics resources currently in FTE Programs across 12 global clients
      • Have grown over 40 FTEs in 2018 and continuing to expand
    • 88% global team retention in 2018 (well above industry standard)
    • Resources located in North America, South America, China and Europe
    • Roles include embedded, dedicated leadership structure + all levels of Data Managers, Stats Programmers, Biostatistics, IVRS, ePRO, Medical Coding
    • Several teams are remote, others partially based in PRA Philadelphia headquarters, others at Sponsor sites, global PRA facilities
    • Management almost always grown from within, with a PRA manager in place for every team
    • Teams range in size from 1 resource to 200+ and several relationships have been established for 5, 10, and 15+ years!

     

    Our motto: One client!  One team!  One set of processes to learn!

     

    Why join SSD Biometrics?

    • PTO policy is very competitive
    • Employee Stock Purchase Plan
    • Have you had a chance to see our sweet office in Blue Bell? 
    • Significant return rate of PRA ex-employees 
    • Get involved in client initiatives, process improvements, investigator meetings, training, mentoring…..break out of the day-to-day
    • See the results of your work through direct discussions, meetings, townhalls and teambuilding events with client leadership
    • Upward mobility for those that are interested – our SSD leadership structure is primarily built from within and have been in place with us for 5, 10+ years!  
    • High retention of team members and management means stable teams and positive program culture
    • Permanent PRA employees with examples of opportunities to convert to client perm roles
    • Significant global industry conference participation, SCDM, JSM, PhUSE, PharmaSug, DIA. We had 32 abstracts submitted for SCDM this year, 10 attendees and 6 presenters in Seattle!

    Responsibilities

    What will you be doing?

     

     

    As a Principal Lead Clinical Data Manager, you will oversee the data management strategy and project plans for collection and integration of all clinical data including but not limited to, case report forms (CRF) data, lab data, biomarker data, and patient reported outcomes for one or more trials within a specific drug program.  You will lead cross-functional, global teams to ensure all aspects of the project plan (from data management trial planning through submission components) are executed on time and with appropriate quality.  You will serve as a project manager for data management activities and represent global data management for assigned trials.

    Qualifications

    What do you need to have?

     

    Education: Bachelor’s degree preferred

    Experience:  7 years of data management experience preferred

     

    Skills:

    • Manage all operational aspects of clinical trials in compliance with GCP regulations, PRAHS policy and Client Company policy.
    • Manage project and timelines across Client programs and studies.
    • Ensure timeliness of deliverables for each phase of the study from study start-up through production and close-out activities.
    • Interact with various Data Management and other functional area colleagues, including, but not limited to: Biostatistics and Programming, Clinical, Safety, Medical Coding, site personnel.
    • Ensure Clinical Data Management staff maintains all relevant documentation associated with each assigned Protocol.
    • Identify and work collaboratively and cross-functionally to implement process improvement measures within data management on both departmental and project level.
    • Coordinate with Clinical Data Management Staff, Client, and Study Team to identify issues/trends for discussion.
    • Lead study/project team meetings as primary facilitator of timelines, providing updates on study status to the cross functional team.
    • Escalate any potential or actual issues in a timely manner and follow issues through to resolution.
    • Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation.
    • Serve as primary point of contact for all project timeline related communication.
    • Monitor and work to maintain/improve stakeholder satisfaction by ensuring high quality service, communication, and management of clinical data.
    • Lead and facilitate all project team meetings.



    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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