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Associate Director, Clinical Data Management Quality @Iovance

[Hiring] Associate Director, Clinical Data Management Quality @Iovance

Apr 10, 2025 - Iovance is hiring a remote Associate Director, Clinical Data Management Quality. 💸 Salary: unspecified. 📍Location: USA.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

The Associate Director, Clinical Data Management quality, provides technical and operational expertise to ensure Iovance Clinical Data Management establishes and follows practices, processes, and tools used to ensure accuracy of Clinical Trials data is accurate, consistent and reliable. This position will lead and coordinate functions for multiple assigned projects related to the planning, execution, collection, and cleaning of clinical data.

  • Expertise in clinical data management systems (CDMS) and data validation tools
  • Develop procedures for the CDM Quality group to establish and maintain high quality data throughout the lifecycle, including collection and cleansing
  • Develop and execute data validation plans to identify and address data inconsistencies, errors, or outliers
  • Implement quality control measures to proactively identify and prevent data quality issues
  • Work to improve clinical data management processes to ensure optimal procedures
  • Perform validation activities to verify the functionality and integrity of the data management systems
  • Establish and promote use of standards
  • Stay updated with relevant regulatory guidelines (e.g., FDA, ICH) and ensure all data management practices comply with these standards
  • Document data management quality processes and procedures to support regulatory audits
  • Communicate data quality issues and concerns to relevant parties, including study investigators and project management
  • Audit potential data management vendors, as appropriate
  • Serve as a technical resource to colleagues; troubleshoot technical problems
  • Coordinate the transfer of clinical data between all vendors participating in a clinical study
  • Assist in the compilation of clinical data for regulatory submissions
  • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics
  • Perform miscellaneous duties as assigned

Qualifications

  • 10+ years of CDM experience with 4 - 5 years of management experience
  • Excellent verbal and written communication skills and strong interpersonal skills are required
  • Demonstrated ability to manage people
  • Experience with Electronic Data Capture (EDC) & other data management systems
  • Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner
  • Strong understanding of clinical research methodologies and regulatory requirements

Requirements

  • Must be able to remain in a stationary position standing or sitting for prolonged periods of time
  • Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects
  • Must have visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading
  • This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers
  • Must be able to communicate with others to exchange information

Work Environment

This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.

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Back to Remote jobs  >   All others
Associate Director, Clinical Data Management Quality @Iovance
All others
Salary 💸 unspecified
Remote Location
USA
Job Type full-time
Posted Apr 10, 2025
Apply for this position Unlock 54,270 Remote Jobs
📍 Be aware of the location restriction for this remote position: USA
Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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