Nimisha Manikandan
Burghausen
Kurzprofil
Motivated and detail-oriented Pharma professional seeking a position to leverage expertise in Pharmacovigilance, Clinical Research, Clinical Data Management, and Medical Writing, complemented by knowledge in Clinical Pharmacology and Pharmacotherapeutics.
Übersicht
5
5
years of professional experience
1
1
Certification
Berufserfahrung
Clinical Research Associate Trainee
Pharmaakademie
Munich, Germany
2026.06 - Current
- Clinical Research: Clinical Trial Management, Monitoring Processes, and CRA Workflow.
- Regulatory Compliance: ICH-GCP, EU Clinical Trial Regulation (CTR), GMP, GVP, and GxP Standards.
- Clinical Operations: Site Management, Monitoring Visits, Study Start-up, and Site Initiation Activities.
- Clinical Documentation: TMF Management, Essential Documents, CRF/eCRF Review, and Inspection Readiness.
- Clinical Data Management: Data Review, QA/QC, Data Integrity, and Query Management.
- Regulatory Affairs: Ethics Committee Submissions, Regulatory Documentation, and Clinical Trial Regulations.
- Study Management: Clinical Trial Planning, Study Coordination, and Project Management.
- Medical Writing: Scientific, Clinical, and Regulatory Documentation.
Clinical Research Associate
Aosta India Private Limited
Tamil Nadu, India
2022.11 - 2024.03
- Clinical Trial Monitoring: Supported Phase I-IV clinical trials across Oncology, Cardiology, Pediatrics, and Reproductive Health.
- Site Coordination: Assisted senior CRAs with site communication, monitoring activities, and study management.
- SDV & Data Review: Performed SDV, SDR, CRF review, and clinical data verification.
- Documentation Management: Maintained study documents, regulatory files, and informed consent records.
- GCP Compliance: Ensured adherence to ICH-GCP, study protocols, SOPs, and regulatory requirements.
- Safety Review: Evaluated ADRs, drug interactions, and patient safety data.
- Quality Systems: SOPs, Audits, Inspections, CAPA, and Quality Management Systems (QMS).
- Study Reporting: Prepared study reports and documentation for sponsor review and approval.
- Cross-functional Collaboration: Worked with Clinical Operations, Pharmacovigilance, Medical Affairs, and Data Management teams.
Intern - Pharm D
Karuna Medical College
Kerala, India
2021.09 - 2022.10
- Consultation & Ward Rounds: Regularly consulted with doctors in the hospital and participated in ward rounds to monitor patient safety and treatment outcomes.
- Prescription Analysis & ADR Assessment: Trained in analyzing prescriptions to assess Adverse Drug Reactions (ADRs), medication errors, and drug interactions, ensuring patient safety.
- Drug Safety Reporting: Prepared detailed reports and forms documenting ADRs, medication errors, and drug interactions, contributing to the pharmacovigilance system.
- Regulatory Affairs Experience: Attended a visit to the quality management system and software regulatory affairs at Karuna Medical College, gaining insights into regulatory practices and systems in healthcare.
Ausbildung
Advanced Diploma - Clinical Research
Clini Launch Research Institute
Bangalore, India 2024 - 2025
Pharm D - Doctor of Pharmacy
Grace College of Pharmacy
Kerala, India 2016 - 2022
Kompetenzen
- Analytical Thinking and Innovation
- Communication
- Leadership and Team building
- Project management
- Conflict Resolution
- Medical documentation and Auditing
- Clinical Research
- Regulatory Text and Data interpretation
- MS Office Suite
Languages
German
First language
English
Advanced
C1
German
Upper intermediate
B2
Hindi
Intermediate
B1
Publication
Drug Utilization Pattern of Estrogen and Progesterone among Women‑ A Prospective Study
- This project mainly focused on the usage and utilization of Estrogen and Progesterone supplementation for various conditions of the reproductive system.
- ADR and the effectiveness of each type of supplementation for various indications were studied.
- The compliance rate was measured and the conclusion was framed.
- Published in International Journal of Current Pharmaceutical and Clinical Research.
Zertifizierung
- Technical Writing: Quick Start Guides - NASBA, 08/24/24
- Medical Writing for Healthcare Professionals - Udemy, 08/26/24
- SAS Essential Training: 1 Descriptive Analysis for Healthcare Research - LinkedIn Learning, 08/29/24
- Quality Management for Operational Excellence - Project Management Institute (PMI), 09/02/24
- Six Sigma: Green Belt - Project Management Institute (PMI), 09/03/24
- Six Sigma: Black Belt - Project Management Institute (PMI), 09/04/24
- Learning SAP Production Planning and SAP MM - LinkedIn Learning, 09/07/24
- Certificate Course in Pharmacovigilance - Udemy, 09/19/24
- Sprachzeugnis Deutsch: B2 - Telc
Zeitleiste
Clinical Research Associate Trainee
Pharmaakademie
2026.06 - Current
Clinical Research Associate
Aosta India Private Limited
2022.11 - 2024.03
Intern - Pharm D
Karuna Medical College
2021.09 - 2022.10
Advanced Diploma - Clinical Research
Clini Launch Research Institute
2024 - 2025
Pharm D - Doctor of Pharmacy
Grace College of Pharmacy
2016 - 2022