Dr. Leeba B. Jacob

MDR - Point of Contact (May 2024 - Present)

Client: AMGEN

• Led and developed a team of Medical Data Reviewers, establishing clear expectations, accountability frameworks, and performance standards to ensure high-quality clinical data review and delivery across multiple studies.
• Drove end-to-end medical data review including analysis of adverse events, key endpoints identifying trends, outliers, protocol deviations, and potential safety signals at a global level.
• Partnered cross-functionally with sponsor stakeholders (Medical Directors, Data Management, Clinical Operations,etc) to align data review outputs with study objectives and regulatory expectations.
• Strengthened quality oversight and compliance by conducting periodic quality reviews, identifying risks, and implementing corrective and preventive actions (CAPA) to enhance data integrity.
• Enhanced team capability through coaching, training, and knowledge-sharing initiatives, contributing to onboarding, continuous learning, and succession planning within the Medical Data Review function.
• Leveraged sponsor-specific digital tools and analytics platforms, including TIBCO Spotfire, to build interactive dashboards, support signal detection, and generate actionable clinical insights.

Medical Data Reviewer (Aug 2023 - Apr 2024)

Client: AMGEN

• Identified anomalies in patient-reported data for further investigation with clinical sites, ensuring overall accuracy of data.
• Reviewed medical data for completeness, accuracy, and compliance with regulations.
• Performed quality assurance checks on medical databases to ensure accuracy of subject medical records.

• Oversaw day-to-day practice functions, patient care, medical and administrative staff and business activities.
• Established policies and SOPs in collaboration with the team to enhance quality control and assurance.
• Played a key role in project initiation, planning, control, and evaluation, user acceptance testing, successful migration, and implementation of the Hospital Implementation Systems and related modules training.
• Engaged in strategic planning initiatives to improve operational efficiency within the organization.
• Monitored quality assurance programs to ensure delivery of high-quality healthcare services.

• Oversaw the operational activities of a three-floored inpatient department, ensuring the efficient management of the medical team across the respective floors.
• Successfully handled administrative responsibilities of nine COVID-19 Intensive Care Units during the COVID-19 pandemic.
• Ensured compliance with all relevant laws governing medical practices.

• Communicated effectively with patients regarding their diagnosis and treatment options.
• Consulted with patients regarding root canals and other dental procedures.
• Collaborated with dental specialists, such as orthodontists and periodontists, to coordinate comprehensive care for patients.