Clinical Data Management Leader

5 days ago


Mumbai, Maharashtra, India KlinEra Global Services Full time
Job Summary

We are seeking a seasoned Clinical Data Management Leader to oversee the planning, execution, and management of clinical data management activities across multiple clinical trials. As a key member of our team, you will be responsible for ensuring the highest data quality, regulatory compliance, and timely delivery of projects.

About the Role

In this leadership role, you will manage a team of clinical data professionals, providing guidance, mentoring, and professional development opportunities. You will collaborate with cross-functional teams, including clinical operations, biostatistics, and regulatory affairs, to ensure seamless project execution. Your expertise in clinical trial software, programming languages (e.g., SAS, SQL), and electronic data capture (EDC) systems will be valuable assets in driving project success.

Key Responsibilities:
  • Data Management Oversight: Lead and manage data management activities for clinical trials, ensuring timelines, budgets, and quality standards are met.
  • Team Leadership: Supervise, mentor, and provide guidance to a team of Clinical Data Managers (CDMs) and other data management staff. Ensure professional development and training opportunities for the team.
  • Study Planning: Collaborate with project teams to design and implement data management plans (DMPs), data collection tools (e.g., CRFs), and systems. Oversee the creation of data management documents such as data dictionaries and edit checks.
  • Quality Assurance: Ensure the highest data quality by implementing quality control processes. Lead data review activities, such as query generation, resolution, and risk-based data validation.
  • Vendor Management: Manage relationships with external data management vendors and provide oversight to ensure service delivery meets expectations.
  • Regulatory Compliance: Ensure all data management activities comply with regulatory requirements (e.g., GCP, FDA, EMA) and the company's standard operating procedures (SOPs).
  • Cross-Functional Collaboration: Work closely with clinical operations, biostatistics, medical writing, and regulatory teams to facilitate smooth data transfer, analysis, and reporting.
  • Reporting and Documentation: Prepare and present reports on data management progress and metrics to stakeholders. Maintain accurate documentation throughout the trial lifecycle.
  • Risk Management: Identify potential risks to data integrity and timelines and work with project teams to implement mitigation strategies.
Requirements:
  • Education: Bachelor's degree in Life Sciences, Medical or Clinical Research, or a related field. Advanced degree (e.g., Master's) is a plus.
  • Experience: Minimum of 5-7 years of experience in clinical data management, with at least 2-3 years in a managerial role within a CRO or pharmaceutical company.
  • Proven Experience: Proven experience in leading and managing a team of clinical data professionals.
  • Expertise: In-depth knowledge of GCP, ICH guidelines, and regulatory requirements related to clinical data management.
  • Skill Set: Strong experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS). Experience with clinical trial software and programming languages (e.g., SAS, SQL) is advantageous.
Estimated Salary Range:

$120,000 - $160,000 per year, based on location and experience.



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