Rashmi Bole_Hardas

• Acts as a key team member during the study start-up process by performing User Acceptance Testing (UAT) of the database, validation procedure testing and providing feedback to the clinical database programmers. • Writes, updates and/or reviews Data Management Plans and other key study documents. • Creates, reviews, and processes Data Clarification Forms and updates the databases. • Manages the clinical data management process for multiple simple or complex trials. • Performs other miscellaneous activities

• Assumes overall responsibility for the successful execution of the data management projects assigned to them. Lead DM with minimal supervision for several midsize to complex projects/partnerships. • Writes updates/reviews and approves all required trial data management documentation, documents and presents CRF completion guidelines at investigator meetings. • Performs any data management activities related to projects, as needed. • Provides leadership and may supervise/train Data Management staff assig

• Maintenance of up to date project related documentation • Preparation of training related documentation • Impart functional training to new recruits • Creation and validation of standard reports produced through customer specific applications • Generating and validating SAS XPT files • Creating and modifying Metadata Document, annotated CRF, eCRF using customer specific applications • Perform User Acceptance Testing (UAT) on assigned projects

- Leading a team of 4 people for a long term trial. - Simulteneously working on a short term trial. - Performed various activities of Data Review for various projects on Adhoc bases. - Worked across different projects - Involved in Study Start-Up, Study Conduct and Study Close-Out activities.

• Generate operational plans for a CDM project • Data review (inclusive of Generation of VAP, UAT, Test cases generation) • Query Management • Documentation of these activities as per SOP needs and job functions • Coordinating with clinical/sponsor contact as required. • CRF designing • Assisting Medical writer in generating clinical study report • Training new staff on Clinical Data Management processes • SOP writing

• Preparation of dossiers according to requirements of different countries (Dossiers prepared for Latin American, African, European, Asian & Middle East countries) • Handling related queries. • Application for Export & Free Sale Certificates • Preparation of Pharmaceutical Expert Report

• Dispensing of medications • Inventory Control