Clinical Trials Data Manager

5 days ago

Vijayawada, Andhra Pradesh, India beBeeData Full time ₹ 9,00,000 - ₹ 15,00,000
Job Title:

Clinical Data Management Specialist

At our organization, we are seeking a highly skilled Clinical Data Management Specialist to join our team. In this role, you will be responsible for managing and analyzing clinical trial data to ensure accuracy, relevance, and compliance with industry standards.

Key Responsibilities:

  • Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design, and Data Review and Reconciliation tools.
  • Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.
  • Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
  • Perform holistic data review and trending analysis via reporting and analytics to proactively identify issues, risks, and develop mitigation strategies.
  • Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.
  • Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead/project manager.
  • Perform Query Management.
  • Define specifications and collaborate with technical teams on configuration of centralized data management platform, elluminate Data Central, for data cleaning strategy and oversight activities.
  • Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.
  • Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules.
  • Collaborate and work as a team to ensure deliverables are completed on time with high quality.
  • Ensure compliance with industry quality standards, regulations, guidelines, and procedures.
  • Other duties as assigned.

Required Skills and Qualifications:

  • Strong understanding of clinical trial data management principles and practices.
  • Excellent analytical and problem-solving skills.
  • Ability to communicate effectively with cross-functional teams.
  • Proficiency in Microsoft Office and ability to learn new software applications quickly.
  • Experience with data management platforms and ability to implement data cleaning strategies.
  • Knowledge of regulatory requirements and industry standards.
  • Bachelor's degree in life sciences, computer science, or related field.

Benefits:

  • Competitive salary and benefits package.
  • Opportunities for career growth and professional development.
  • Collaborative and dynamic work environment.

How to Apply:

To apply for this exciting opportunity, please submit your resume and cover letter to us. We look forward to reviewing your application.

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