Katalyst HealthCares & Life Sciences

Clinical Data Manager

Katalyst HealthCares & Life Sciences South Plainfield, NJ
Katalyst HealthCares & Life Sciences

Clinical Data Manager

Katalyst HealthCares & Life Sciences South Plainfield, NJ
2 weeks ago 55 applicants

See who Katalyst HealthCares & Life Sciences has hired for this role

Responsibilities

  • Act as Lead Data Manager, overseeing all deliverables of activities outsourced to DM CRO for multiple studies.
  • Interact and manage relationships with other functional areas to ensure high quality data management activities.
  • Oversight of data collection tools (EDC, DTAs, EDC integrations) and essential documents. (DMP, UAT Documents, data edit specifications, annotated case books and data entry guidelines)
  • Participate in User Acceptance Testing Activities for the applicable Data Collection Tools.
  • Perform Quality Control for the data completeness and accuracy.
  • Participate in and support data cleaning, query generation and resolution and review of medical coding as needed.
  • Responsible for adhering to the Data Management timelines and budget.
  • Provide technical expertise to help in the use of technologies for Data Management and the clinical study team.
  • Contribute to the development of lessons learned and best practices as well as help develop SOPs and internal working procedures and process improvement initiatives.
  • Contribute to the establishment of systems and tools to help ensure clinical data security and integrity.
  • Contribute to the process to identify, evaluate and select external business partners and technology vendors.

Requirements

  • 10+ years' experience in clinical data management in biotechnology or pharmaceutical industry, with outsourced CRO oversight experience.
  • 7+ years managing vendor relationships/partnerships in a global environment.
  • Must have advanced knowledge of Data Management processes and systems.
  • Oncology experience required.
  • Solid understanding of CDISC standards required
  • Data Visualization Tool experience preferred.
  • Experience using standardized medical terminology, including but limited too MedDRA and WHO Drug.
  • Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a study team environment .

  • Seniority level

    Mid-Senior level

  • Employment type

    Contract

  • Job function

    Information Technology

  • Industries

    Pharmaceutical Manufacturing

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