1970-01-01Davis Companieshttp://daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svgfull-time325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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Clinical Data Analyst

  • Specialty:

    Engineering
  • Title:

    Clinical Data Analyst
    • City:

      Chaska
    • State:

      MN
    • Zip Code:

      55318
  • Start date:

    06-28-2021
  • Status:

    Closed
  • Assignment Type:

    Contract To Hire
  • Job Id:

    59406

Description

Our manufacturing company is seeking a Clinical Data Analyst to join our Team. We’re looking for associates whom thrive in a team-oriented, goal focused environment. You’ll be responsible for following established operation procedures, maintaining appropriate training records for your role, sustaining a smooth flow of material and the execution of work orders to on-time completion. 

Clinical Data Analyst will provide technical and day-to-day application support for the Clinical Affair Organization. He/she will design, program, manage and document database projects and ensure process improvement and the promotion of new tools and techniques. This position is responsible for leveraging the Business System and tools in the timely and high-quality execution of a clinical data management strategy for pre-market and post-market trials.

 

Duties & Responsibilities:

  • Develop the data management plan for clinical studies.
  • Execute the data management plan throughout lifecycle of the study.
  • Participate in developing the case report form (CRF). Develop database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.
  • Develop data transfer agreement(s) between external data sources and/or labs.
  • Assist in database upgrades/migrations including performing user acceptance testing.
  • Maintain/track of EDC user management and other clinical databases across allocated clinical trials, compile master user lists and activate/deactivate user accounts.
  • Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
  • Perform database lock and freeze activities.
  • Coordinate the archiving of study databases and related documents.
  • Perform close-out audits. Ensures data system compliance by following the established guidelines of regulatory authorities.

 

 

QUALIFICATIONS AND EXPERIENCE:

  • Bachelor’s degree in Computer Science, Mathematics, Statistics, Pharmaceuticals Sciences, Life Sciences or related fields and 5+ years’ experience.
  • Must have knowledge and experience with Medidata.
  • SAS, C# or Python.
  • Capability of Medidata study building. CDISC knowledge. Project management and delegation skills.
  • Knowledge and experience in developing study dataset specifications.
  • Previous work experience in a diagnostic, medical device or pharmaceutical.
 
DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace.  We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be.  Apply today and experience “The DAVIS Difference”. 

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