Clinical Data Manager Job at Katalyst HealthCares and Life Sciences, Boston, MA

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  • Katalyst HealthCares and Life Sciences
  • Boston, MA

Job Description

Responsibilities:
  • Provide input on Data Management related study plans including Data Management Plan (DMP), Data Validation Plan, Data Review Plan, CRF Completion Guidelines, and other study documents to ensure quality and standardization; may be responsible for updating DM documents to ensure they are up to date.
  • Contribute to development of initial and updated eCRF designs, including database UAT.
  • ssist in development of global library standards and comply with global library process.
  • Contribute to development and implementation of edit check specifications and work with database programmer on edit check development and validation.
  • Facilitate transfer of data from external vendors, which may include finalizing Data Transfer Agreement/ Specifications and verifying test data per specifications document.
  • Work with internal programmers to develop ad hoc SAS listings, patient profiles, and other outputs.
  • Run and review outputs and database study metrics; identify discrepancies to assist in data cleaning.
  • Participated in data reviews with clinical team to ensure accuracy, consistency, and reliability of data.


Requirements:

  • t least 5 years' experience working as a Clinical Data Manager in the pharmaceutical industry.
  • Experience with DM activities including Database Build, Study Startup, Study Conduct, and Database Closure
  • Hands on experience with Medidata RAVE is required and experience using ad hoc query tools required (JReview, other desired)
  • Must have experience in vendor reconciliation, UAT testing, discrepancy management, etc
  • Experience in CRO and vendor management is a huge plus.
  • Experience with multiple phases of clinical development highly desirable
  • ssociate degree or higher is required, bachelor's degree is preferred.

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