Headline

Clinical Operations Associate | Pivot path Pvt Ltd (Demerged entity of Arcolab) | BA/BE & Clinical trials|PDE & OEL Reports| Python · SQL ·Tableau •Excel •NLP •ML models •AI automation |FDA/EMA/Health Canada/GCC/MHRA|WEU

About

Hello, Welcome to my LinkedIn profile. As a Clinical Operations Associate, my role focuses on ensuring that clinical trials are conducted efficiently while maintaining strict regulatory compliance to help bring innovative therapies to patients faster. My experience in clinical research coordination enables me to support critical study start-up activities, including protocol review, regulatory documentation, and site initiation, while also assisting in effective site management throughout the trial lifecycle. By working closely with cross-functional teams such as regulatory affairs, data management, pharmacovigilance, quality assurance, and finance, I help ensure smooth communication and operational alignment so that studies progress seamlessly from initiation to close-out. Operating in a highly regulated environment requires adaptability and strong attention to detail, and I remain committed to upholding the principles of Good Clinical Practice (GCP), ensuring protocol compliance, protecting patient safety, and maintaining the integrity and reliability of clinical trial data. Let's connect and collaborate on advancing clinical development! Expertise : >Preparation of Non-Clinical Overview (NCO) , Clinical Overview (CO) (module 2.4 & 2.5), Clinical and non clinical summary (module 2.6 & 2.7) >Development of Permissible Daily Exposure (PDE) and Occupational Exposure Limit (OEL) reports. >Performing product evaluations. >Performing systematic literature searches to support regulatory submissions. >Responding to regulatory authority queries. >Monitoring Bioavailability/Bioequivalence (BA/BE) studies and clinical phase trials. >Reviewing study protocols and Clinical Study Reports (CSR). >Ensuring protocol compliance in accordance with regulatory requirements of EMA, Health Canada, WHO, FDA, and NPRA. >Identifying and documenting protocol deviations. > Maintaining TMF and providing weekly project status >Execution of confidentiality disclosure agreements, Master service agreements, consultant agreements with clients & vendors. >Collaborating cross-functionally with Finance, Legal, and Quality Assurance teams to support project execution. > Coordination with finance team for the tracking of invoices, update payment status. > Solution driven, process optimization with AI assisted application development ( Claude, GPT, Gemini, Antigravity) Additional skill sets: Hypothesis testing Data analytics visualization Data Forecasting Data driven decision making Product analytics Root cause analysis RFM Model (Customer segmentation) A/B Testing

Location

Greater Bengaluru Area

AI stack

antigravity

claude code

claude

gemini

openai

Work experience

Associate-Clinical operations at Pivot Path, Jun 2026 - Present · 6 mos, Bengaluru, I'm excited to share the next step in my professional journey as I transition from Arcolab to Pivotpath a demerged entity focused on advancing innovation and excellence in the life sciences space. As we embark on this new chapter with PivotPath, I look forward to contributing to innovative solutions, embracing new challenges, and helping drive meaningful impact across the life sciences industry. #PivotPath #LifeSciences #NewBeginnings #Innovation #PharmaceuticalIndustry #CareerGrowth #HealthcareInnovation #Teamwork#Professional Development#EPIC#Arcolab

Clinical Operations Associate at Arcolab, Feb 2025 - Present · 1 yr 10 mos

Clinical operations (Trainee) at Arcolab, Feb 2024 - Feb 2025 · 1 yr 1 mo, *Involved in review of Protocol , Clinical study reports , BA reports, designing of CT protocol. *Preparation of PDE Reports, Annual safety reports, toxicological assessment for extractables and leachables, f-value determination *Monitoring of BA/BE studies, clinical trials Phase-III, Medical device trials. * Support for the ANDA approval process, *Preparation of NCO & CO, clinical strategy document, summary documents * Ensure Guideline compliance, adherence to GDPR Regulations * Answering Regulatory Queries within stipulated timeline * Product Evaluation for relevant markets. *Performing effective literature search, compilation and medical writing. *Continuous learning with training programs and effective team coordination

Clinical pharmacist at Sree Siddaganga medical college & Research institute, Dec 2022 - Dec 2023 · 1 yr 1 mo, Tumkur, Karnataka, India, *participation in Ward rounds *Check patients treatment chart for Drug interaction *Reporting ADRs with detailed case narration * preparation and provision of requested drug information service to HCPs *Medication review in the drug carts *Data analysis and Research based on trend or case flow (observational and intervention al approach) *patient counseling along with designing and distribution of PIL *Measuring medication adherence with relevant questionnaire * Good experience with few cases under the oncology and Neurology department with best doctors.

Education

Doctor of Pharmacy - PharmD, Clinical pharmacology, Sree Siddaganga College of Pharmacy

Advanced program in Clinical research, clini india