• Lead Data Manager

    Job Locations (All) | US-NJ | US-PA-Philadelphia
    Posted Date 2 weeks ago(12/5/2018 11:05 AM)
  • Overview

    Responsible for successfully providing data management deliverables that meet internal and external client needs.


    • At least five (5) years clinical data management experience.


    • Experience as a Lead Data manager
      • At least one (1) full year as a Lead Data Manager, including at least 1 study start/setup, and also at least 1 database lock.


    • Electronic data capture (EDC) experience is mandatory.
      • A minimum of two (2) years experience with a major EDC tool such as InForm, RAVE, Oracle Clinical, or similar.
      • Experience should include:
        • Study startup/build activities, including working with a standards library;
        • User Acceptance Testing (UAT);
        • Data Review and Cleaning (run queries, run reports);
        • Data Reconciliation.
    • Extensive experience managing study start-up, conduct and lock in the data management space:
      • Knowledge of and familiarity with a Standards Library, and mapping of protocols to data standards;
      • Success in conducting/leading meetings, include User Review (OLSR – OnLine Screen Review) meetings;
      • Involvement with cross-functional teams including Programming and Biostatistics;
      • Success in managing external vendors providing additional study data such as labs, PK, etc.;
      • Knowledge of ePRO/eCOA instruments and their use in clinical studies.


    • Documented experience in translating clinical protocols into electronic case report forms and developing the associated data validation specifications (e.g., edit checks, reports).


    • Proven ability to run multiple concurrent studies while also participating in special projects or process improvement initiatives. Should also have the ability to represent the department on cross-functional study teams, and cross functional project teams.


    • Demonstrated experience in providing customer-focused support, with satisfactory examples provided.


    • Excellent written and verbal communication skills:
      • At a minimum, PRA should review candidate’s resume for written skills. No spelling or grammatical errors, clearly expressed thoughts and examples, etc.
      • PRA to screen for verbal skills during interview. Includes but not limited to clearly spoken, grammatically correct English .  English does not have to be their first language but the candidate should have sufficient skills to be able to lead meetings with confidence.
      • Candidate should also have solid presentation skills. This includes a proven ability to represent both him/herself and also the department in front of customers and stakeholders.


    • Stress resistant / ability to work within short and compressed study timelines.
      • Candidate should be informed of the EDEV environment, specifically with regards to studies that could go from Start-up to DBL in a few months, and the associated need to deliver high-quality databases in these compressed timelines.
      • PRA to determine if the candidate has prior experience working in such an environment (early phase). If not, PRA should assess the candiate’s potential for success in these situations.
      • An ideal candidate will have prior early phase experience, include a successful study start and a successful DBL.


    • Ability to multi-task, work independently, and act with appropriate accountability
      • Candidate should be informed of the standard workload expectations of an EDEV Lead, such as the ability to run concurrent studies in different phases (once the candidate is on-board and suitably trained and mentored if appropriate).
      • Candidate should be informed of the expectation of being able to participate in special initiatives in addition to study work.
      • Candidate should be able to demonstrate full self-accountability to lead studies according to Merck processes, interact with customers and stakeholders, complete assigned training & trackers with minimal supervision.



    • Phase 1 experience
    • Experience with InForm
    • Experience with external data vendors: understanding specifications to import multiple types of data, working with technical groups to ensure timely loads of external data sets into the sponsor database.
    • Understanding logistics in the laboratory space (e.g. PK/PD analysis, sample management...)
    • Ability to reasonably explain any gaps in the timeline of their resume.
    • College degree is desirable but not required if supplemented by sufficient work experience.

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


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