Ashlesha Anand Pawar

Coordinate and support the day-to-day activities of clinical trials as per the study protocol.Ensure ethical conduct and patient safety throughout the study.Assist in patient screening, recruitment, enrollment, and follow-up.Obtain and document informed consent from study participants.Maintain accurate and complete study documentation (source documents, CRFs, patient files).Ensure compliance with ICH-GCP guidelines, SOPs, and regulatory requirements.Coordinate with investigators, sponsors, CROs, and ethics committees.Schedule and manage site visits, monitoring visits, and audits.Report and document adverse events (AEs) and serious adverse events (SAEs).Handle investigational product (drug) accountability and storage.Support regulatory submissions and ethics committee documentation.Assist in data entry, query resolution, and database lock activities.Participate in study initiation, training, and close-out activities.

Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project-specific information.
Undergone Pharmacovigilance Training for the projects as AstraZeneca, Novartis And Mankind Pharma.
Reporting drug related Adverse (AE) and serious adverse events of the patients to respective clients.
Maintenance of Trial Master File for each project.
Transmission of documentation into project files.
Reconciliation Filling of project correspondence.
Maintenance investigator database and a QC of the database.
Work closely with the patient participants and clients to support their needs.
Making weekly and monthly Consolidated reports for clients.
Ability to work independently and in a team.
Strong attention to detail and project management skills.

Ensure accurate Completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project-specific information., Undergone Pharmacovigilance Training for the projects as AstraZeneca, Novartis And Mankind Pharma., Reporting drug related Adverse (AE) and serious adverse events of the patients to respective clients., Maintenance of Trail Master File for each project., Transmission of documentation into project files., Reconciliation Filling of project correspondence., Maintenance investigator database and a QC of the database., Work closely with the patient participants and clients to support their needs., Making weekly and monthly Consolidated reports for clients., Ability to work independently and in a team., Strong attention to detail and project management skills.

Developed and implemented a streamlined documentation system for samples and product testing.
Collaborated with cross-functional teams to ensure accurate and timely completion of product documentation.
Implemented a quality control process for sample and product testing.
All the Necessary Details Regarding Training have been taken.

Developed and implemented a streamlined documentation system for samples and product testing., Collaborated with cross-functional teams to ensure accurate and timely completion of product documentation., Implemented a quality control process for sample and product testing., All the Necessary Details Regarding Training have been taken.

Coordinated clinical trial activities from initiation to close-out, ensuring adherence to protocol, ICH-GCP, and regulatory requirements.
Assisted in screening, enrolling, and monitoring study participants as per inclusion/exclusion criteria.
Managed essential documents, including informed consent forms, CRFs, logs, and regulatory binders.
Maintained accurate source documentation and ensured timely data entry in EDC systems.
Acted as liaison between investigators, sponsors, CROs, and ethics committees.
Supported site monitoring visits, audits, and inspections, ensuring preparedness and compliance.
Oversaw investigational product accountability and maintained trial supplies.
Contributed to study close-out, proper archiving, and documentation handover.

Coordinated clinical trial activities from initiation to close-out, ensuring adherence to protocol, ICH-GCP, and regulatory requirements., Assisted in screening, enrolling, and monitoring study participants as per inclusion/exclusion criteria., Managed essential documents, including informed consent forms, CRFs, logs, and regulatory binders., Maintained accurate source documentation and ensured timely data entry in EDC systems., Acted as liaison between investigators, sponsors, CROs, and ethics committees., Supported site monitoring visits, audits, and inspections, ensuring preparedness and compliance., Oversaw investigational product accountability and maintained trial supplies., Contributed to study close-out, proper archiving, and documentation handover.