Manjula Sridharamurthy

On a planned career break, concurrently pursuing an Executive Programme in Business Administration at ISB to build strategic and general management capability alongside clinical operations expertise.

Led end-to-end data management for full-service global studies, from database design, validation rules, and edit checks through data cleaning, query resolution, and lock. Owned Data Management Plans, managed vendor relationships and study financials, and contributed to RFP development and process improvement.

Directed full-scope data management for global studies across Oncology, Immunology, and Neurological disorders, from database design and CRF development through UAT and lock. Designed risk-based data management strategies, oversaw query management and quality metrics, managed budgets, and mentored junior staff.

Delivered assigned global studies on time by owning DM milestones and aligning expectations across internal and external partners. Partnered with sponsors to define eCRF content and data quality standards, reviewed documentation for regulatory readiness, and delivered training at investigator and monitor meetings.

Oversaw CRO database design, data cleaning, query, and reconciliation activities to ensure timely, high-quality deliverables. Authored and reviewed DM Plans, Data Transfer Agreements, and edit checks, and contributed to CRO and vendor selection and SOP development.

Managed Trial Master File documentation, study data in IMPACT systems, and study finance/invoicing via eCLIPS. Served as primary liaison for regulatory/IRB-EC submissions, managed the Green Light Packet Processing Plan, and delivered CRO training on regulatory requirements.

Contributed to Data Management Plans, led database UAT, and performed discrepancy management and SAE/vendor reconciliation across paper and EDC studies. Conducted manual and SAS listing reviews and escalated complex data issues.

Ran cell-based assays (Caspase-3, TUNEL, flow cytometry, BCA/Nano-Orange) and molecular techniques (SDS-PAGE, Western blotting, cell culture). Contributed to peer-reviewed research published in PLOS ONE.

Bio-curated pharmacology, hormone, nutrition, and pharmaceutical research data into structured databases.

Pursuing an Executive Programme in Business Administration to build strategic and general management capability.

Master of Science in Bio-Technology from Bangalore University.

Bachelor of Science in CZBt from Bangalore University.