Open to opportunities

Bala Randhi

@balarandhi

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Experienced Clinical Data Manager with over 11 years in data management.

United States

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What I'm looking for

I am seeking a role that offers opportunities for leadership and collaboration, where I can leverage my extensive experience in clinical data management to drive project success and foster team development.

I am a Clinical Data Manager with over 11 years of experience in data management within the clinical, CRO, and pharmaceutical industries. My expertise spans managing trials through all phases of their life cycle, ensuring accountability, transparency, and high-quality deliverables. I have a proven track record of success in managing multiple trials in various models, including FSP and fully outsourced settings.

Throughout my career, I have developed strong leadership skills, fostering collaboration and trust among internal and external stakeholders. I have worked across multiple therapeutic areas, including oncology and cardiovascular, utilizing tools such as Medidata Rave and Oracle Clinical. My role as a Senior Manager at Bristol-Myers Squibb has allowed me to lead cross-functional teams, ensuring timely and reliable clinical trial data delivery while maintaining high standards of quality and compliance.

Experience

Work history, roles, and key accomplishments

Current

Senior Manager, Clinical Data Manager

Current

Bristol-Myers Squibb

May 2021 - Present (4 years)

Responsible for end-to-end clinical data management activities, leading cross-functional study teams, and ensuring high-quality clinical trial data delivery. Conducts data quality reviews, manages vendor performance, and provides oversight for junior data managers. Works across multiple therapeutic areas including oncology and cardiovascular.

Project Management Data Quality Stakeholder Management Tableau

Sr. Clinical Data Manager

Otsuka

Mar 2019 - Apr 2021 (2 years 1 month)

Managed end-to-end data management activities for global clinical trials, ensuring operational feasibility of protocols and monitoring trial health. Provided strategic input into protocol design and conducted quality oversight of data management processes.

Risk Assessment QC Oversight Data Management Team Leadership

Sr. Clinical Data Manager

IQVIA

Jul 2015 - Feb 2019 (3 years 7 months)

Led data management activities for multiple sponsors, ensuring high-quality deliverables and documentation management. Conducted training for CRO/CRA on protocols and developed department standards for data management.

Data Management Documentation Management Training Quality Assurance SOP Development Data Validation Team Collaboration

Clinical Research Coordinator

VA Medical Center

May 2012 - Jun 2015 (3 years 1 month)

Supported project management in clinical trials by monitoring site performance, developing clinical monitoring plans, and preparing study documents. Evaluated vendor performance and tracked budget utilization.

Clinical Monitoring Plan Budgeting Compliance Monitoring ECRF Review