Clinical Data Strategist

2 weeks ago

Alwar, Rajasthan, India beBeeClinicalData Full time ₹ 9,00,000 - ₹ 12,00,000

The Role: Clinical Data Specialist

Job Summary:

We are seeking a seasoned Clinical Data Specialist to join our team. The successful candidate will be responsible for managing and coordinating all aspects of clinical data, ensuring the highest level of quality, accuracy, and timeliness in data delivery.

This individual will work closely with cross-functional teams to define project specifications, integrate external data collections, and develop data cleaning strategies. They will also utilize AI and ML for anomaly detection, monitor key performance indicators (KPIs), and ensure compliance with industry standards.

Key Responsibilities:
  • Data Management: Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design, and Data Review and Data Reconciliation tools.
  • 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: Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
  • Trending Analysis: Perform holistic data review and trending analysis via reporting and analytics to proactively identify issues, risks, and develop mitigation strategies.
  • AI/ML Implementation: Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.
  • Performance Monitoring: 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.
  • Centralized Platform Configuration: Define specifications and collaborate with technical teams on configuration of centralized data management platforms.
  • Documentation Maintenance: Prepare and maintain data management documentation, such as DMPs, CCGs, Help Text, and DVSs, throughout the trial lifecycle.
  • Quality Control: Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and analytics modules.
  • Collaboration: Collaborate and work as a team to ensure deliverables are completed on time with high quality.
  • Compliance: Ensure compliance with industry quality standards, regulations, guidelines, and procedures.
Requirements:

To succeed in this role, you should have a solid background in clinical data management, excellent analytical skills, and the ability to work effectively in a team environment.

You should also possess strong communication skills, attention to detail, and the ability to meet deadlines.

Experience with AI and ML is a plus, but not required.

What We Offer:

We offer a competitive compensation package, opportunities for professional growth and development, and a collaborative work environment.

If you are passionate about clinical data management and are looking for a challenging opportunity, please apply.

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