Pharmacologist | Clinical Research | Site Start-up Expert PROFILE SUMMARY: Experienced Pharmacist with expertise in pre-clinical and clinical research, seeking opportunities in leading organizations. Knowledge of industry guidelines such as ICH-GCP, GDP, NDCT Rules, USFDA, EMA, and ICMR Biomedical research guidelines. Skilled in pharmacogenomics, pharmacoeconomics, and drug discovery and development. Proficient in protocol writing, scientific writing, and medical writing. Strong team player with a proven track record of successful project outcomes. Excellent communication and presentation skills. SKILLS: Site identification and feasibility assessment Team collaboration and project management Protocol writing and clinical study report preparation IRB/IEC coordination and investigational product management Safety pharmacology and pharmacoepidemiological studies Regulatory compliance and submission management Budget negotiation and CTA execution Quality control and document management Proficient in MS Office, eTMF, SharePoint, Box, and various clinical research applications CURRENT ROLE: Site Start-up Associate at Premier Research | Ensuring Quality Deliverables and Compliance | Proactive Forecasting and Submission Timelines | Essential Document Collection and Review | Investigator Contract and Budget Negotiation | Trial Master File Compliance | Regulatory Submissions and Notifications | Informed Consent Review | Liaising with Internal Teams | QC of eTMF Documentation EDUCATION: Master in Pharmacy (Pharmacology) | RGUHS, Banglore | 2020 Bachelor in Pharmacy | RGUHS, Banglore | 2018 CERTIFICATIONS: ICH-Good Clinical Practice E6 (R2) | The Global Health Network Introduction to Clinical Research | The Global Health Network Introduction to Pharmacovigilance | Uppsala Monitoring Centre Molecular Docking by using a tool like Autodock. CONFERENCES/WEBINARS: National Symposium on 'Radiation and Radiopharmaceuticals for Healthcare' E-Poster Presentation on 'Evaluation of Anti-convulsant Activity of Root Extracts of Cassia fistula Linn in Rats' Seminar on 'Regulatory Prospects in Drug Product Development and Clinical Data Management' Webinar on 'Bioequivalence' Ready to contribute skills and experience to a leading organization. Open to new opportunities in the pharmaceutical and clinical research industry.