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.
• 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.
• Advanced planning and risk management for projects (issue escalation, resource management).

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

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.

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.

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..

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.

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+