Bineesh Mekalampatta

Head, Clinical Data Management @Kailera Therapeutics

Boston, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2025 — Present

Head, Clinical Data Management @Kailera Therapeutics

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Boston, MA, US

As the Head of Clinical Data Management, ensure the integrity and timely delivery of high-quality clinical data across the Kailera’s portfolio. Oversee data management activities conducted by strategic partners, CROs, and other third-party vendors, ensuring adherence to best practices and regulatory requirements. Drive the implementation of data management best practices, manage data operations, optimize resource allocation, and serve as a subject matter expert for internal initiatives focused on process improvement, training, and compliance. Build and maintain strong relationships with functional service providers to enhance data management capabilities and support the company’s evolving needs.

EDUCATION

N/A

ISBM

Master's degree, Management, Project Management

N/A

Society for Clinical Data Management (SCDM)

CCDM Certification, Clinical Data Management

2018 — 2020

Framingham State University

Master of Business Administration - MBA, Management, Biotechnology Operations

N/A

University of Kerala

Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences

SKILLS

Cross-Functional Team LeadershipSoftware DocumentationEdcTherapeutic AreasCtmsRegulatory AffairsData ManagementValidationClinical TrialsClinical DevelopmentIch-GcpMedical WritingCdiscClinical Data ManagementOracle ClinicalComputer System ValidationClinical MonitoringRegulatory RequirementsPharmaceutical IndustrySopFdaClinical Operations21 Cfr Part 11Regulatory SubmissionsBiotechnologyClinical ResearchPharmacovigilanceCRODrug DevelopmentOncologyProtocolGcpCrf Design

ABOUT BINEESH MEKALAMPATTA

Leading DM teams to deliver end-to-end quality deliverables of data management activities including study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. Developing and implementing data management strategy to support innovation and advancement, and capitalizing DM expertise.Specialties: Clinical Research, Project Management, Program Management, Clinical Data Management, Clinical Operations, Business Performance Management and ICH GCP.

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