Pooja Ghorapade, Ccdm® Email & Phone Number

Bristol, Gb

Exeter, England, United Kingdom

•Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.•Develop Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.•Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.•Coordinate and participate in DM activities of clinical trials from eCRF design and build, study conduct, user training, to database lock and delivery of high-quality data.CRF designing, testing and validation for the studies.•Interact and collaborate with other project and speciality team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.•Advanced planning and risk management for projects (issue escalation, resource management).•Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.•Assist with goal creation and performance review assessment for data review project staff.•Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.•Identify areas for process and efficiency improvement and implement solutions on assigned projects.•Support achievement of project revenue and operating margin for data management activities to agreed targets.•Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.

Mumbai, Maharashtra, India

• Worked on Multicentric Mega clinical trials from data management perspective • Discrepancy management in Rave, ECE, Jarvis & Pinnacle 21 and followed up with clinical sites and respective stakeholders for resolution.• Reconciliation of Serious Adverse Events (SAE) between eCRF and Safety data• Performed external data reconciliations like LAB, PD and IVRS etc. • Quality control of Data Management activities performed by team members • Created VBA (Advance excel) programs to automate tasks/Reports• Created DTG, DMP Designed eCRF, Edit check specification• Performed Edit check development, user acceptance testing (UAT), data cleaning, reviewing listings, and database locking procedures • Responsible for the implementation of clinical study database, startup documents, reports and external data

India

 Led the collection of non-CRF data during study set up, conduct & close out activities across multiple studies, contributing to fit for qualities.  Created & maintained Data Handling Strategy (DHS) & File specification format (FFS).  Managed CDM non-CRF deliverables, identified risks & coordinated cross functional tasks with adequate understanding of upstream & downstream processes, as applicable. Implemented, maintained and approved non CRF Vendor Transfer Agreements/plans/ specificationsImplemented/maintained non CRF checks that ensure structural data quality, conformance to established format specifications

Mumbai, Maharashtra, India

 Status reporting timelines negotiation of the projects to responsible stake holders for UAT activities Escalated the challenges/issues to the respective team. Managed resources allocation & supported as required and contribute towards creation of test cases, documentation, and communication with internal customers for SAS listings, data transfer, data import activities. Mentored to Validation Team Members/New joiner’s in all validation activities & for expected compliance matrices  Channeled project/VTM metrics support to other Validation Team Lead & Manager.

Mumbai, Maharashtra, India

Discrepancy Management Contributed in developing and training team on use of DTE specific tools to evaluate & improve the quality and integrity of the study data. CAPA for non-compliant issues per e-CRF guidelines & clinical operation plan (COP)  Facilitated study specific analytics strategy by preparing 3 individual trackers on different matrices. Ensured complete and accurate documentation of all the study specific tools and templates, keep the project audit ready including Medidata RAVE, CTMS, Clinephone/IXRS, Infosario Analytics, Wingspan/TMF. Performed trigger management and facilitated i-site-pack for respective sites and countries for assigned study(ies).

Mumbai Area, India

Documented, tracked & labeled study activities & SAE forms using relevant forms and tools. Tracked SAEs coming into department to compile SAE packs. Created, Updated & maintained triage. Task allocated per Triage to all team members on daily basis. Tracked filing of documents in global database Argus 8.0 basic and Intake. Created & approved File notes for discrepant reports.

Master'S Degree, Project Management

Master Of Business Administration(Mba), Leadership & Global Strategy Planning, A

Post Graduation Diploma In Management, Business Analytics

Advanced Pg Diploma In Clinical Research And Business Management, Clinical Research, A+

Bachelor Of Science (B.Sc.), Chemistry, Botany, A+