Senior Clinical Data Management Specialist

1 day ago

Rajkot, Gujarat, India beBeeClinical Full time ₹ 8,00,000 - ₹ 12,00,000
Clinical Data Management Specialist Job Description

The Clinical Data Management Specialist plays a pivotal role in ensuring the integrity and accuracy of clinical trial data. This individual is responsible for defining project specifications, understanding external data collection, and executing data cleaning strategies to accelerate time to achieve subject data cleanliness.

Key Responsibilities:

  • Data Management Services: Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design, and Data Review and Data Reconciliation tools.
  • External Data Integration: Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.
  • Data Cleaning Strategies: Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
  • Holistic Data Review: Perform holistic data review and trending analysis via reporting and analytics to proactively identify issues, risks, and develop mitigation strategies.
  • Artificial Intelligence and Machine Learning: Utilize AI and ML for anomaly and outlier detection to enhance the efficiency and quality of trial data.
  • Key Performance Indicators: Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study leads/project managers.
  • Query Management: Perform Query Management.
  • Data Platform Configuration: Define specifications and collaborate with technical teams on configuration of centralized data management platforms, elluminate Data Central, for data cleaning strategy and oversight activities.
  • Data Management Documentation: Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycles.
  • Quality Control: 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.
  • Collaboration and Teamwork: Collaborate and work as a team to ensure deliverables are completed on time with high quality.
  • Regulatory Compliance: Ensure compliance with industry quality standards, regulations, guidelines, and procedures.

Requirements:

  • Bachelor's degree in Computer Science, Information Technology, or related field.
  • Proven experience in Clinical Data Management, preferably in a pharmaceutical or biotechnology company.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Familiarity with data management systems, such as elluminate Data Central.

Benefits:

  • A competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.

How to Apply:

Please submit your application, including your resume and cover letter, to [insert contact information]. We look forward to hearing from you

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