Rajshree Khed

Lead Clinical Data Management operations supporting global clinical studies across multiple therapeutic areas while driving quality, compliance, operational excellence, and talent development.

Leadership & Organizational Management

• Lead and mentor a team of 15 Clinical Data Management professionals supporting global clinical trials.
• Drove resource planning, forecasting, utilization management, and development of organizational capabilities.
• Successfully recruited and onboarded talented Clinical Data Management professionals, strengthening team capability and supporting business growth.
• Contribute to business growth through bid defenses and business development initiatives.
• Served as a POSH Committee Member, fostering an inclusive and compliant workplace culture.

Portfolio Oversight

• Provide strategic oversight for 36 active clinical studies from study start-up through database lock and closeout.
• Ensure successful delivery of study start-up , conduct,database lock, and closeout activities.
• Collaborated with project management, biostatistics, statistical programming, medical monitoring, coding, and sponsors to ensure successful study execution.
• Lead issue resolution, risk mitigation, and escalation management activities.

Sponsor & Client Management

• Act as a key sponsor-facing representative for Clinical Data Management.
• Participate in governance meetings, risk reviews, timeline discussions, and study oversight activities.
• Support proposal development, feasibility assessments, and operational planning activities.

Quality, Audit Readiness & Compliance

• Championed audit-ready culture through proactive quality oversight, coaching, document management.
• Supported five client audits and ensured readiness for inspection activities.
• Ensured compliance with internal procedures, sponsor requirements, GCP, and ICH guidelines.

Innovation & Process Improvement

• Led CDS adoption and SAS-based automation initiatives, improving efficiency, quality, and oversight.
• Reduced portfolio-wide data cleaning effort by 13.7%, with 75% of studies showing lower cleaning requirements.
• Developed cross-regional RACI frameworks, strengthening governance, accountability, and collaboration across global teams.

• Led global Clinical Data Management delivery for complex clinical studies, ensuring quality, timeline, and budget adherence.
• Managed study execution, resource planning, forecasting, and risk mitigation while engaging sponsors to align objectives.
• Mentored team members and implemented process improvements that streamlined operations and enhanced team capabilities.

• For all the above roles supported global clinical trials through data review, validation, reconciliation, database lock activities, and quality oversight