Santhosh Kumar Padamatinti
Global Trial Management| Full Development Phase| HOCT| Global Development Operations| R&D
- Role
- Senior Global Trial Specialist at 百时美施贵宝
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Santhosh Kumar Padamatinti
Over 16 years experienced in Clinical Research Industry & Expertise in- Project…
Experience
Senior Global Trial Specialist
Aug 2023 — Present · Hyderabad, IN
Project Management: • Provides operational input and facilitates operational processes as an SME in support of the startup, maintenance, and closure of studies. • Uses performance metrics and quality indicators to assist and in driving study execution. • Identifies issues and risks, develops mitigations, and escalates appropriately. • Resolves routine problems and escalates important issues appropriately (with a sense of urgency). • Actively contributes as a key functional member on cross-functional teams.• Functions as a Mentor and key resource for GTS team members.• Acts as a Subject Matter Expert (SME) for applicable systems/processes.• Contributes to the operational execution of clinical studies at various stages to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP and applicable SOPs.• Provides support for management of study deliverables (i.e, timelines, study plans, documents, etc.) through collaboration with internal and external stakeholders. • Drives process/system enhancements related to GTS responsibilities/deliverables and manages/complies with various quality or compliance systems. • Participates on cross-functional study teams. • Supports performance and quality oversight of Contract Research Organization (CRO) teams and/or vendors. • Contributes to the achievement of corporate and study team goals, successfully completes assigned tasks and sets priorities with guidance. • Proactively manages multiple assignments and operational processes with moderate to minimal supervision. • Has high functional impact on the study team and the organization.
Skills
- Quality Assurance
- Clinical Data Management
- Clinical Monitoring
- E3
- Validation
- Sop Development
- Irb
- CRO
- Informed Consent
- Protocol
- Clinical Trials
- Schedule Y
- Pharmacovigilance
- Regulatory Requirements
- Ich
- Clinical Research
- Regulatory Submissions
- E6
- Protocol Review
- Ectd
- Inspection
- Gcp
- Site Monitoring
- Dcgi
- Iec
- Quality Auditing
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