Expert Clinical Data Strategist

4 days ago

Nellore, Andhra Pradesh, India beBeeClinical Full time ₹ 1,72,80,000 - ₹ 2,59,20,000

Job Opportunity: Senior Clinical Data Manager

We are seeking a highly experienced Senior Clinical Data Manager to join our team. As a key member of the data management team, you will be responsible for ensuring the accuracy and integrity of clinical trial data.

Key Responsibilities:

  • Manage and maintain CTMS platforms, including CRIO, RT CTMS, Veeva Vault CTMS, and other similar systems.
  • Configure and administer EDC systems, with a strong understanding of system integrations and electronic systems validation.
  • Ensure compliance with regulatory requirements, including HIPAA, FDA, EMA, and ICH-GCP guidelines.
  • Lead cross-functional teams in the development and implementation of clinical data management strategies.
  • Develop and maintain documentation, processes, and procedures for data management operations.

Requirements:

  • 10-15 years of experience in clinical trial/data management and data operations.
  • Minimum 4-5 years of people management (preferred) experience with proven supervisory skills.
  • Extensive experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas.

Technical Expertise:

  • CTMS configuration and administration skills (CRIO knowledge is an advantage).
  • Deep knowledge of EDC platforms and system integrations.
  • Strong understanding of regulatory requirements.

Education and Certifications:

  • Bachelor's degree in Computer Science, Information Technology, or related field.
  • Certifications in data management, project management, or related fields (desired).

Why Join Us?

At this dynamic organization, we offer a work environment that fosters innovation, collaboration, and growth. Our team is passionate about delivering high-quality solutions that make a meaningful impact on people's lives. If you're a motivated and detail-oriented professional looking for a new challenge, we encourage you to apply for this exciting opportunity

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