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Clinical Data Management - Principal Trial Manager

Siemens

Pune, Hyderabad

·

3 w

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Full time

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Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Clinical Data Management - Principal Trial Manager A dynamic organisation seeks an experienced Clinical Data Management - Principal Trial Manager to take on a multifaceted and impactful role. This is an opportunity to be part of a purpose-driven team reshaping industry standards and best practices. Principal Responsibilities: Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Develop SOPs, work instructions, and training materials for clinical operations teams. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Review source data and ensure completeness, accuracy, and regulatory compliance. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Candidate Requirements: 5+ years of experience with demonstrated progression in scope, complexity, and responsibility. Sound understanding of organisational dynamics and stakeholder management in complex environments. Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. Critical and strategic thinking skills with the ability to translate insights into clear actions. Advanced competency in analytical tools, reporting platforms, and role-specific technology. Recognised qualification in the relevant professional field at the undergraduate or graduate level. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We value talent and invest in our people this role offers both professional challenge and meaningful rewards.