Sen Ipsita

To be a part of an organization, where there is a scope to enrich my skills and to be focused on the objectives assigned, as well as adding value to the organization and develop professionally and intellectually. I consider myself a responsible and orderly person with a friendly and conscientious personality. I have experience in various Pharmacy domain. Armed with a strong and thorough work ethic, I can be relied upon as a personnel.

Clinical Research Associate at Abbott Medical Devices (2025-07 – Present)

• Regulatory Submission: Acquiring study approvals
• Preparation of Study Protocols
• Maintaining Database of CSP cases
• Keeping Patients data maintaining confidential requirements
• Attending CSP cases for recording and maintaining case data
• Calling for Patient Follow-up visit accordingly
• Submission of Academic trials for paper publications in various scientific journals

Clinical Research Associate at RegClin Consultancy Solutions (RCCS) (2025-06 – Present)

• Registration of Ethics Committee CDSCO & DHR
• Registration of NABH & NABL
• CTRI Registration
• CRO Registration
• Paper Publication Works
• Conducting Clinical Trials at Various sites
• QA & QC work regarding Clinical Trials Performance
• Initiation of Sites: Start-up work
• SAE Reporting
• SOP Development
• CRF/eCRF & Protocol Designing
• ICFs Translation team

Manager Regulatory Affairs & Academics at Infoclin Consultancy (2023-10 – 2025-07)

• Regulatory Submission: CDSCO Approval for conducting Trials
• Ethics Committee Registration & Re-registration to CDSCO
• DHR Registration & Re-registration to NECRBHR
• Regulatory Submission: Re-constitution of Ethics Committees
• SOP Preparation
• CTRI Registration to ICMR
• EC Coordinator: Conducting EC Meetings & maintaining ethical compliances
• Sponsor Communication: Start-up activities
• SAE Reporting to CDSCO

Executive Regulatory Affairs & Academics at Infoclin Consultancy (2022-08 – 2023-09)

• Regulatory Documents Preparation: Service Agreement, CDA, CTA, MOU, MOM etc.
• Presentations & Newsletter Preparation for various studies
• SAE Reporting to CDSCO
• Quality Control checking: Regulatory Documents PI Site Mapping

Hospital Pharmacist at National Urban Health Mission, Department of Health & Family Welfare Samiti, Govt. of India (2017-01 – 2022-08)

• Dispensing prescribed drugs to the patients at UPHC.
• Maintaining records of all drugs, equipments, other consumables of UPHC along with proper inventory mechanisms.
• Placing indent for refilling of drugs and other consumables of UPHC in regular interval.
• Indenting of drugs and consumables for UPHC so that adequate buffer stocks are maintained in anticipation of a sudden health emergency.
• Submission of Consume entry reports within scheduled time.
• Follow up with the sub-standards batch if any and take actions accordingly.
• Conducting Child Camps & Participate in UHND and special outreach camps.
• Maintaining Immunization Supply Chain System (ISCS).
• Maintaining Pregnancy Units with proper care.
• Participating in Medical Health Care Units in emergency purposes.
• Participating in the project of State Urban Development Agency (SUDA) for the prevention and control of Dengue.
• Organize and participate in different National Health Programme.

Clinical Data Management at Cognizant Technology Solutions (2016-09 – 2017-01)

• Hands on experience on Database: Medidata RAVE, Oracle Clinical, Macro.
• Handling studies: Start-up phase, Conduct phase and Quality Control (QC) study.
• Performing User acceptance Testing (UAT).
• Review and provide input to Project Data Management Plan on the assigned Client protocols maintaining the SOPs.
• eCRF Design & Database Design: For a clinical trial an Electronic Case Report Form database design and CRF design is utilized.
• Data Compilation: Review and assess all source documents and compile data in an adverse event report.
• Computer System Validation (CSV) process should be maintained.
• Analyze data from the Safety database and Project database.
• Central Laboratory Data Collection along with other external datas.
• Serious Adverse Event Reconciliation.
• Design and deliver agreed status reports at a study level by ensuring the status of delivery.
• Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required.
• Database Finalization & Extraction: Accountable for responding to post DB lock questions or queries.
• Quality Control: Responsible for overall quality and integrity of study database for assigned studies.

M.Pharm in Pharmacy – Guru Nanak Institute of Pharmaceutical Science And Technology (G.N.I.P.S.T) (2014 – 2016)

B.Pharm in Pharmacy – Guru Nanak Institute of Pharmaceutical Science And Technology (G.N.I.P.S.T) (2010 – 2014)

I.S.C – St. Augustine's Day School (2008 – 2010)

I.C.S.E – St. Augustine's Day School (2008)

PhD in Pharmacy – Pursuing