プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Karishma B.に依頼

Switzerland

Clinical Research & Clinical Operations Consultant | PhD, PMP | GCP, Quality & Medical Writing

プロフィール概要

Clinical Operations and Project Management professional with a PhD in Life Sciences, MBA, and PMP® certification, bringing **3+ years of direct clinical research and clinical trial coordination experience** alongside 10+ years of scientific and translational research experience. My background spans hospital-based clinical research, MedTech clinical operations, quality systems, regulatory compliance, and scientific project leadership. I have supported global clinical studies through study coordination, TMF/eTMF management, quality documentation, audit readiness, safety documentation, stakeholder management, and cross-functional collaboration. My experience includes working with investigators, sponsors, CROs, ethics committees, and multidisciplinary project teams across academia and industry. Most recently, I supported Clinical Operations and Quality activities at Teleflex Vascular Intervention, contributing to clinical study documentation, quality processes, safety workflows, monitoring support, SOP updates, and compliance activities within a regulated MedTech environment. Earlier, I coordinated clinical research activities in collaboration with leading academic hospitals, including participant follow-up, study documentation, regulatory support, and clinical data management. In addition to clinical research and operations, I have extensive experience in scientific writing, literature reviews, publications, medical communications, project management, and stakeholder engagement. I have authored peer-reviewed publications, delivered scientific presentations, and managed complex multidisciplinary projects throughout my career. Areas of expertise include Clinical Operations, Clinical Trial Coordination, TMF/eTMF Management, Quality & Compliance, GCP, Regulatory Documentation, Medical Writing, Scientific Review, Literature Research, Study Start-Up Support, and Project Management. Available for freelance assignments across Switzerland and Europe.

専門分野

• ★ Molecular Biology
• ★ ISO 13485
• ★ Clinical Trials
• ☆ Biostatistics
• ☆ Biochemistry
• ☆ Immunoassay
• ☆ Biochemical Assays
• ☆ Apoptosis
• ☆ Oxidative Stress & Mitochondrial Function
• ☆ Enzyme Activity Assays
• ☆ Binding Assays
• ☆ Biomarkers
• ☆ Omics
• ☆ Transcriptomics
• ☆ Proteomics
• ☆ Genomics
• ☆ Chromatin
• ☆ Epigenetics
• ☆ PCR
• ☆ Molecular Cloning
• ☆ Next Generation Sequencing (NGS)
• ☆ DNA Sequencing
• ☆ Gene Expression Analysis
• ☆ Mutagenesis
• ☆ Recombinant DNA
• ☆ RNA Synthesis
• ☆ RNA Sequencing
• ☆ DNA/Gene Synthesis
• ☆ Oligonucleotide Synthesis
• ☆ Plasmid DNA
• ☆ DNA Damage & Repair
• ☆ ChIP-Seq
• ☆ Monoclonal Antibody Production
• ☆ Cell Biology
• ☆ Cell-Based Assays
• ☆ Cell Signaling Pathways
• ☆ Gene Regulation
• ☆ Histology
• ☆ Biotechnology & Bioengineering
• ☆ Recombinant Protein Expression
• ☆ Microscopy
• ☆ Cryosectioning
• ☆ Light Microscopy
• ☆ Fluorescence Microscopy
• ☆ Biomarker Discovery
• ☆ Cell Culture
• ☆ Primary Cells
• ☆ Cell Line Engineering
• ☆ Large Scale Cell Culture
• ☆ Cell Surface Receptors
• ☆ Chemical Biology
• ☆ Biomolecular Engineering
• ☆ Gene Editing/CRISPR
• ☆ Protein/Enzyme Engineering
• ☆ Blotting
• ☆ Immunohistochemistry
• ☆ Cell Aging
• ☆ Drug Development
• ☆ Drug Substance Characterization
• ☆ Biosafety Testing
• ☆ Microbiology Testing
• ☆ Bioanalytical Testing
• ☆ Drug Stability Testing
• ☆ Preclinical ADME/PK/PD
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ In vitro Preclinical Toxciology
• ☆ Drug Efficacy Testing
• ☆ Antibiotic Development
• ☆ Vaccine Development
• ☆ Medical Devices
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Medical Implants
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 14971
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Cardiovascular Disease
• ☆ Pacemakers
• ☆ Clinical Laboratory Science
• ☆ Clinical Pathology
• ☆ Molecular Pathology
• ☆ Regulatory Affairs
• ☆ Gene Therapy

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Research Scientific and Technical Research, Systematic Literature Review

Consulting Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Quality Assurance & Control (QA/QC)

職務経験

Senior Postdoc

ETH Zurich

9月 2022 - 現在

Clinical Operations & Trial Management Support

Teleflex Medical

12月 2025 - 5月 2026

Postdoctoral fellow

Max Planck Institute of Immunobiology and Epigenetics

1月 2020 - 3月 2023

Senior Research Fellow

Shiv Nadar University

11月 2019 - 12月 2019

PhD Scholar

Shiv Nadar University

8月 2014 - 9月 2019

JUNIOR RESEARCH FELLOW

Translational Health Science and Technology Institute

4月 2012 - 6月 2014

学歴

Postdoc

ETHZ - ETH Zurich - Switzerland

9月 2022 - 7月 2025

認定資格

• PMP

  PMI

  9月 2025 - 現在

出版物

PREPRINT

Karishma Bakshi and Easa Nagamalleswari and Jan Breucker and Nathalie Eisenhardt and Richa Tiwari and Rom{\'{a}}n Gonz{\'{a}}lez-Prieto and Chronis Fatouros and Viduth K Chaugule and Heekyoung Lee and Dragana Ilic and Fredrik Trulsson and Gerhard Mittler and Alfred C.O. Vertegaal and Andrea Pichler(2022). Multi-level monitoring of EME1-MUS81 in CPT induced nucleolar rDNA repair . []. Cold Spring Harbor Laboratory

Easa Nagamalleswari and Karishma Bakshi and Jan Breucker and Michaela Gschweitl and Rom{\'{a}}n Gonz{\'{a}}lez-Prieto and Nathalie Eisenhardt and Chronis Fatouros and Viduth K Chaugule and Alfred C.O. Vertegaal and Andrea Pichler(2022). UBC9 and EME1 sumoylation foster ribosomal DNA damage repair in CPT response . []. Cold Spring Harbor Laboratory

JOURNAL ARTICLE

Karishma Bakshi and Saheli Mitra and Veerendra Kumar Sharma and Magani Sri Krishna Jayadev and Victoria Garcia Sakai and Ramaprasad Mukhopadhyay and Ashish Gupta and Sajal Kumar Ghosh(2020). Imidazolium-based ionic liquids cause mammalian cell death due to modulated structures and dynamics of cellular membrane . Biochimica et Biophysica Acta (BBA) - Biomembranes. 1862. (2). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 183103. Elsevier {BV}

Karishma Bakshi and B. Ranjitha and Shraddha Dubey and Jaisri Jagannadham and Bharti Jaiswal and Ashish Gupta(2017). Novel complex of HAT protein TIP60 and nuclear receptor PXR promotes cell migration and adhesion . Scientific Reports. 7. (1). Springer Science and Business Media {LLC}

Saumya Anang and Chandru Subramani and Vidya P. Nair and Sheetal Kaul and Nidhi Kaushik and Chandresh Sharma and Ashutosh Tiwari and CT Ranjith-Kumar and Milan Surjit(2016). Identification of critical residues in Hepatitis E virus macro domain involved in its interaction with viral methyltransferase and ORF3 proteins . Scientific Reports. 6. (1). Springer Science and Business Media {LLC}

Vidya P. Nair and Saumya Anang and Chandru Subramani and Abhilasha Madhvi and Karishma Bakshi and Akriti Srivastava and Shalimar and Baibaswata Nayak and Ranjith Kumar CT and Milan Surjit(2016). Endoplasmic Reticulum Stress Induced Synthesis of a Novel Viral Factor Mediates Efficient Replication of Genotype-1 Hepatitis E Virus . PLOS Pathogens. 12. (4). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString e1005521. Public Library of Science ({PLoS})