Clinical Trial Operations Specialist

4 days ago

Palakkad, Kerala, India beBeeClinicalDataManagement Full time ₹ 12,00,000 - ₹ 20,00,000

Job Description:

  • This position is responsible for defining project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.
  • The ideal candidate will have experience in clinical data management, preferably in the pharmaceutical or biotechnology industry.
  • They will be responsible for ensuring the integrity and quality of clinical trial data, collaborating with cross-functional teams, and driving process improvements.
  • This role requires strong analytical and problem-solving skills, as well as excellent communication and collaboration skills.
  • Key Responsibilities:
    • Define project specifications for Data Management services.
    • 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(s)/project manager.
    • Perform Query Management.
    • Define specifications and collaborate with technical team on configuration of centralized data management platform 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 analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.
    • Collaborate and work as a team to ensure the deliverables are completed on time with high quality.
    • Ensure compliance with industry quality standards, regulations, guidelines, and procedures.

About this role:

This is a dynamic role that requires strong analytical and problem-solving skills, excellent communication and collaboration skills, and the ability to drive process improvements.

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