CV of Swagata Ghosh

Curriculum Vitae

Ms Swagata Ghosh

Overall Experience Summary:1.5+ Years Experienced as Clinical Research Professional

Education:

Post Graduate Diploma in Clinical Research and Regulatory Affairs (2013) Jadavpur University, Kolkata, West Bengal

MSc in Human Physiology (2012) University of Calcutta, Kolkata, West Bengal BSc in Human Physiology (2010) University of Kalyani, West Bengal

Positions /Appointments:

Officer- Clinical Operation and Consumers Insighting Product Innovation Research – EMAMI LIMITED, Kolkata (since APRIL 2014)

Clinical Research Coordinator- CLINOVATION RESEARCH PVT. LTD., Kolkata (NOVEMBER 2013 – MARCH 2014)

Clinical Research Coordinator (Trainee)- CLINOVATION RESEARCH PVT. LTD., Kolkata (AUGUST2013 – NOVEMBER 2013)

Clinical Research / Pharmaceutical Research Experience:1. Clinical Trials / Site Management (SMO)

Communicate with sponsor / CRO and regulatory bodies Perform site and investigator selection Act as primary contact person of studies for all clinical trial-related activities Co-ordinate with Ethics Committee of trail site for any regulatory issues for each trial and find specific

solutions to the same. ICF consenting/reconsenting process Source documentation process Accessing ClinPhone IWRS/IVRS system Safety reporting procedure Completion & correction of eCRF Patient Recruitment Patent visit scheduling, planning and Follow Up Sample collection Maintenance of Investigator Site File Communicating and Safety reporting of subjects to IEC, Sponsor and DCGI Maintenance of Investigational Product

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Residence: Contact no.:c/o Mr Subrata Ghosh +91 9681590036Bowbazar, East Lane City: Krishnanagar [email protected].: NadiaPin: 741101 State: West Bengal,India

Curriculum Vitae

Site feasibility Sound awareness of all relevant regulations, including GCP Screening and Enrollment of study subjects. Maintaining Site Master Files AE monitoring, reporting and follow up of study. IEC/IRB correspondence including SAE submission, all essential documents. Managing all trial activities including site initiation, sponsor visit, auditor visit etc. Review regulatory documents (e.g., protocols, amendments, IBs, CSRs, summary documents, appendices,

and clinical trial disclosures) for data accuracy against source data and consistency between the document text and the in-text tables

Prepare site for SIV Preparation, attendance and follow-up of monitoring and audit. Assisting the Principal Investigator in screening, enrollment and follow up of patients in clinical trial. Maintaining source documents and Maintaining clinical laboratory reports and other reports of clinical

investigations. Investigational product management, dispensing, temperature monitoring and accountability Supervision & coordination for the collection, processing and shipment of clinical Laboratory samples to

central laboratory. Perform Data capturing from the source note to EDC.

2. Clinical Trials Management for Cosmetic Products (Hair-care, Skin-care & Personal-care products)

Prepare Standard Operating Procedures Assist in procuring and calibrating equipment by external agencies Obtain IQ, OQ, PQ ,DQ etc. for equipments Perform Volunteer/Subject Management (registration, recruitment & screening) Prepare and compile CRF, ICF ,Protocol and SMF Administer ICFs Compile Clinical Trial Documents Train staff on SOPs Communicate with central IEC Perform Clinical trial planning, design Manage the conduct of trials for various products of Skin care, Hair care, Pain

Management divisions Co-ordinate trial report review and finalization Review claims for cosmetics and assist in approval of these claims Performed equipment-based evaluations / clinical testing of product efficacy for skin lightening, skin

moisturization, anti-sebum, anti-aging, hair growth promoting, anti-hairfall, and pain management products.

Used Equipment such as Cutometer, Corneometer, Tewameter, Glossymeter, Sebumeter, Trichoscan, VISIA Image analysis system etc., for evaluating a wide range of products including skin creams, body lotions, antiperspirants, anti-acne products, anti-aging products, shampoos, oils for hair, scalp and body massage etc.

Data analysis and report preparation

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Curriculum Vitae

Participation in Training Programs, Seminars, Conference:

“Operational Level training on equipment” from respective vendor, 2014 Workshop on “Essentials of business communication”, 2014

DECLARATIONI hereby declare that the information furnished above is true and is to the best of my knowledge and belief.

Name with Signature: Ms Swagata GhoshDate: Place:

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CV of Swagata Ghosh

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