Senior Clinical Data Manager Job at Katalyst Healthcares & Life Sciences, New York, NY

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  • Katalyst Healthcares & Life Sciences
  • New York, NY

Job Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description



Responsibilities:

  • Develop and implement data management plans and procedures for clinical trials.
  • Oversee the collection and validation of clinical trial data.
  • Ensure data quality and accuracy through data review, query resolution, and data cleaning.
  • Work with cross-functional teams, including biostatistics, clinical operations, and medical writing.
  • Ensure compliance with regulatory and industry standards.
  • Participate in the development of clinical study protocols and case report forms.
  • Manage data transfer and reconciliation between different systems.
  • Generate study-specific data management reports.
  • Provide input into the development of project timelines and resource planning.
  • Maintain knowledge of relevant industry and regulatory guidelines.
  • Develop and maintain data management standards and best practices.

Requirements:

  • Bachelor's degree in life science or related field.
  • Minimum of 5 years of experience as a Clinical Data Manager in the biopharmaceutical industry.
  • Familiarity with CDISC standards and guidelines.
  • Knowledge of clinical trial design and statistical analysis.
  • Experience with Electronic Data Capture (EDC) systems.
  • Knowledge of regulatory guidelines, including FDA and ICH guidelines.
  • Excellent analytical and problem-solving skills.
  • Strong written and verbal communication skills.
  • Ability to work independently as well as in a team environment.
  • Strong attention to detail and accuracy.

Additional Information



All your information will be kept confidential according to EEO guidelines.

Job Tags

Contract work, Immediate start,

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