Clinical Data Operations Leader

2 days ago

Rajahmundry, Andhra Pradesh, India beBeeData Full time ₹ 1,52,00,000 - ₹ 2,56,00,000

Job Overview:

  • We are seeking a seasoned professional to lead our clinical trial and data management operations, ensuring seamless delivery of high-quality data.

Responsibilities:

  • Oversee the development and implementation of effective data management strategies to drive business growth.
  • Manage a team of data managers, providing guidance on CTMS configuration and EDC system administration to maximize efficiency.

Requirements:

  • A minimum of 10-15 years of experience in clinical trial/data management and data operations, with a proven track record of success.
  • At least 4-5 years of people management experience, with a strong emphasis on supervisory skills and team leadership.

Technical Expertise:

  • CTMS (CRIO, RT CTMS, Veeva Vault CTMS) and EDC systems management expertise is essential for this role.
  • Familiarity with regulatory requirements, including HIPAA, FDA, EMA, and ICH-GCP.
  • Electronic systems validation and 21 CFR Part 11 compliance knowledge is required.

Preferred Experience:

  • Candidates with experience working in the pharmaceutical or biotechnology industry, across multiple therapeutic areas, will be preferred.

Working Conditions:

  • Work environment: Office setting with frequent travel to client sites.
  • Work schedule: Full-time position, Monday through Friday, standard office hours.

Salary Range:

  • Competitive salary range based on experience and qualifications.

Benefits:

  • Comprehensive benefits package, including medical, dental, and vision coverage.
  • 401(k) retirement plan with company match.

Additional Information:

  • Must have excellent communication and interpersonal skills.
  • Ability to work effectively in a fast-paced environment, prioritizing tasks and managing multiple projects simultaneously.

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