Clinical Trials Data Integrity Specialist

6 hours ago

Karachi, Sindh, Pakistan beBeeQuality Full time 6,000,000 - 8,000,000

We are seeking a dynamic and detail-oriented Quality Assurance Associate to join our team.

The ideal candidate will possess excellent communication skills, be highly organized, and have a strong attention to detail.

Responsibilities:

  • Perform quality control checks to ensure compliance with regulatory requirements and SOPs.
  • Identify and track source documentation errors and non-conformances with requirements.
  • Collaborate with the Clinical Team to share audit/inspection observations for lessons learned across protocol and/or program.
  • Develop risk mitigation plans in conjunction with applicable team members.
  • Performs quality reviews of key documents developed for use in clinical trials.
  • Assist in preparing for Sponsor and FDA audits.
  • Conduct internal audits to review key processes.
  • Establish effective partnerships with internal staff to facilitate timely identification and resolution of compliance and quality matters.
  • Query resolution and data entry regarding respective studies.
  • Other related Quality Assurance projects as assigned.

Requirements:

  • Excellent communication and interpersonal skills.
  • Strong organizational and time management skills.
  • Ability to maintain confidentiality and handle sensitive information.
  • Experience with quality assurance principles and regulations (e.g. GCP, ICH).
  • Proficiency in MS Office applications.
  • Familiarity with database management systems.

Benefits:

  • A competitive salary and benefits package.
  • Ongoing training and development opportunities.
  • A collaborative and dynamic work environment.

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