Senior Clinical Data Manager

3 days ago

Hyderabad Secunderabad Telangana, India beBeeDataScientist Full time

Job Title: Senior Clinical Database Developer

Key Responsibilities:
  • Lead Data Management activities for assigned trials, ensuring timely and quality deliverables through effective collaboration with study teams and functional lines.
  • Provide expert guidance on data management processes, including database design, data validation, and analysis/reporting.
  • Oversee the development of protocols and amendments, ensuring they meet regulatory requirements and business objectives.
  • Recognize and resolve protocol issues that may impact database design, data validation, and/or analysis/reporting.
  • Manage local lab setup for the Clinical Database as applicable.
  • Accountable for all aspects of Process and Training within remit to ensure full compliance to all applicable global regulatory requirements is maintained and business objectives are achieved.
  • Accountable for all quality-related aspects, centralizing and aligning DCOs for audits and inspections.
  • Manage and measure Quality, coordinating exception requests, deviations, and corrective/preventative action plans.
  • Perform DM hands-on activities during the course of the study, ongoing review of all data generated from the clinical study, including Third-party and local lab data as well as SAE reconciliation where applicable.
  • Responsible and accountable to ensure consistency of assigned trials with program-level standards across DM documentation.
  • Generate study status reports for use at Clinical trial team meetings.
  • Support and assist junior staff for assigned trials, providing effective input into DM initiatives and innovations for quality, efficiency, and continuous improvement in scientific and operational excellence.
  • Serve as primary study lead, establishing and maintaining strong working relationships with study teams, and functional lines.
Required Skills and Qualifications:
  • Clinical Data Management.
  • Data Governance.
  • Data Integrity.
  • Data Management.
  • Data Quality.
  • Data Science.
  • Databases.
  • Project Management.
Benefits:

Achieve high level of quality, timeliness, cost efficiency, and customer satisfaction across Data Mgmt activities and deliverables.

No critical audit findings due to Data Mgmt - Adherence to Novartis policy and guidelines - Customer/partner/project feedback and satisfaction.

Others:

This role requires a strong understanding of data management processes, excellent communication skills, and the ability to work effectively in a team environment.

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