Clinical Data Manager in Danvers, Massachusetts at Leica Biosystems

Date Posted: 11/15/2018

Job Snapshot

Job Description

Job ID: ADV000962

About Us

Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps.  Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Visit LeicaBiosystems.com  for more information.

Leica Biosystems Imaging, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check. 

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Description

  • Provide Clinical data management support to clinical team, study projects, and biostatistics team.
  • Develop the data management plan for a clinical study.
  • 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.
  • Will build databases within Medidata.

Job Requirements



Qualifications

  • Bachelor's or Master's degree in technical or health care area with 4+ years of experience in developing and executing clinical data management procedures and thorough knowledge of clinical research.
  • Continuing education in clinical trial designs and monitoring procedures, FDA regulations and clinical data processing and reporting. 
  • Experience or knowledge building databases with Medidata or Medidata Rave would be highly desirable
  • Working knowledge of GCP, FDA, ICH, CDISC, etc., regulations and guidelines
  • Constructive interaction with inter and intradepartmental team members and personnel.
  • Good organizational skills, problem-solving abilities, time management skills and initiative.  
  • Flexibility and ability to work on several assignments simultaneously.  Must be able to work independently as well as part of a team.  
  • Good written and oral communications skills in the English language.  
  • Travel (approximately 5%, domestic and international)  to other business locations, vendors or customers.

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Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.