PRAHS

2017-40628

- | US-Remote | US-KS-Lenexa | Canada-Remote | US-PA-Blue Bell | US-TX | US-IL | US-MA-Boston | US-NJ | US-NY | US-NC-Raleigh...
12 hours ago
Title
Senior Data Manager - Clinical Trials Experience Required (Work from Home)

Overview

The Senior Data Manager ensures that data management services are delivered in a consistent, high-quality, and timely manner. They ensure efficient data flow within the clinical site. They lead the development and implementation of data management project deliverables according to PRA and/or client Standard Operating Procedures (SOPs).

Responsibilities

  • Follows PRA and/or client SOPs to develop, implement, validate, review, oversee and/or maintain:
    • Accurate CRFs and Source Documents.
    • Data Management Plan, edit specifications, and all documents required to be present in the TMF for DM.
    • Timely delivery of efficient data entry screens for clinical databases.
    • Timely delivery of efficient data validation programs for clinical databases.
    • Timely delivery of SDTM deliverables (aCRF, SDTM datasets, SDTM define.xml).
  • Achieves successful delivery of deliverables meeting internal and external client needs by:
    • Serving as the primary client liaison for data management issues.
    • Serving as primary client liaison for CRF/SD completion.
    • Planning and overseeing timelines for activities during the life of the project where data management is active.
  • Works actively in project team environment by:
    • Guiding the clinical staff on CRF/SD completion.
    • Participating in internal and client meetings.
    • Reporting project status to Project Manager.
    • Proposing solutions to procedural and technical issues.
    • Mentoring other staff members including clinical staff.
    • Adhering to financial and administrative processes such as managing project budget and timelines, estimation of resource needs.
  • Manages and/or conducts routine tasks for:
    • SD and/or CRF data flow in the clinic and in data management.
    • Review of the clinical data.
    • Execution of the data validation programs and reports to facilitate data review.
    • Review of the data discrepancies within clinical databases.
    • Generation and tracking of queries from data management and data update forms from the clinic and monitor.  Delivery of queries to the site or CRA.
    • Interaction with investigational sites and/or CRA during query resolution process.
    • Correction of the clinical database in accordance with the edit specifications and in response to query replies.
    • Quality control review of clinical data, including external data receipt and reconciliation.
    • Locking the clinical database, including electronic data transfers to sponsors.
    • Archiving appropriate study information.
  • May contribute to business development efforts in data support.
  • Participates in PRA initiatives for implementation and integration of new data support processes or systems.
  • Knowledgeable in SDTM standards.

Qualifications

  • Bachelor’s degree in a health, quantitative, or scientific field (or its international equivalent from an accredited institution) required.
  • Experience with clinical data management systems required.
  • Experience managing data for clinical trials within the pharmaceutical industry required. Should be able to run a study with questions from other DMs.
  • Demonstrated ability to provide leadership of Data Management activities for a clinical trial (including oversight of other Data Managers) required.
  • Recent Phase 1 experience leading and managing studies is required.
  • Oracle Clinical/Oracle Clinical RDC experience (5+ recent years) is required.
  • Leadership skills are very important for this role. Must be able to work independently and should be motivated to learn and grow in this role.
  • Must be able to work in Microsoft office applications.
  • Experience with the coding of medical terms desired.


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

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