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NKMax America Inc

Clinical Data Manager

CLIN OPS · Santa Ana, California
Department CLIN OPS
Employment Type Full-Time
Minimum Experience Manager/Supervisor
Compensation $70,000 - $110,000

Clinical Data Manager

Job Summary

Responsible for data management activities including, but not limited to, developing data management plans, department SOPs, performing database development, testing, validation, reviewing and processing clinical trial data to ensure completeness, accuracy and consistency of clinical trial databases. Develops electronic database systems for collecting and organizing data to analyze, identify and report trends.

 

General Responsibilities

  • Provides input on study protocol design related to data collection and management
  • Design and modify study specific CRFs/eCRFs, annotated CRFs, and EDC edit checks
  • Work cross-functionally to establish and maintain standard CRFs and edit checks
  • Develop and implement Data Management SOP
  • Responsible for building, review and validation of clinical databases
  • Work with CRA to collect and monitor clinical trial data
  • Work with CRA to review data, highlight and resolve discrepancies
  • Performs all data management activities with no or minimal supervision, including but not limited to database development, testing, validation, site training and support, query resolution, audit, lock, and archive
  • Reconciles adverse events and serious adverse events
  • Ability to maintain 4 to 5 study databases and data management activities concurrently
  • Ensure accuracy and completeness of the clinical data, able to work independently towards assigned goals
  • Proactively identifies potential study issues/risks and recommends/implements solutions
  • Ensure timely execution of database lock per study and company timelines
  • Maintains and prepares final archival of data management documentation relevant to the assigned clinical studies, and assists the Clinical Trial Team (CTM) in assembling and archiving the documentation
  • Validates and disseminates real-time study monitoring reports to CTM
  • Other duties as assigned or required

*The company reserves the right to add or change duties at any time.

Job Qualifications & Skills

  • Bachelor’s degree in Life Sciences, Computer Sciences, Mathematics, health related field or equivalent experience.
  • 5 years of data management experience in pharmaceutical or biotechnology industry
  • Excellent communication, organization and tracking skills; project management skills desirable.
  • Working knowledge of scientific principles and medical terminology
  • Oncology background preferable.
  • Thorough understanding of clinical research methodology including study design, concept development, protocol writing and preparation and knowledge of GCP and local regulatory requirements.
  • Demonstrated ability to accurately and effectively evaluate medical/scientific literature and apply knowledge to study design.
  • Solid teamwork, organizational, interpersonal, and problem-solving skills; exercise good judgement with respect to NKMax America’s confidential information and strategies.
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
  • Knowledge of industry standards (CDISC, SDTM, CDASH).
  • Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.
  • Proven ability to work both independently or in a team setting.

 

 

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  • Location
    Santa Ana, California
  • Department
    CLIN OPS
  • Employment Type
    Full-Time
  • Minimum Experience
    Manager/Supervisor
  • Compensation
    $70,000 - $110,000