Prarthana Prabhakaran

Keen on exploring and growing in different spheres of Clinical Research along with adapting to the continuous evolving nature of the industry. Dedicated to using my knowledge of Clinical research and project management abilities to optimize management, organization and reporting of clinical data.

• In Novartis: Received three 'Above and Beyond' awards for the contribution towards the trial.
• In Novartis: Was recognized for my contributions on the blockbuster drug in 2017.

• Extensively worked on Oncology trials and other therapeutic areas like Cardiovascular, Endocrinology and infections diseases across different phases.
• As a Lead and Trial data manager, have successfully locked critical trials and have supported many submission trials.
• Have at length worked on maintenance and Close out activities of the study as a DM Lead.
• Ensured all work performed is of high quality, compliant with GCP, ICH guidelines and all applicable laws and regulations.
• Have worked towards understanding study protocol, contract and scope of work for all task during set-up, maintenance and close out of the study.
• Review all activity on an ongoing basis to identity out of scope tasks. Assist in compiling the change order log.
• Have identified database required changes and ensured successful post production changes to the database.
• Ensure effective implementation of standard metric and status reporting on the study.
• Perform project planning tasks and support in the development of the project plan and timelines. Set up and maintain data management study files for inclusion in the TMF, ensuring these are maintained in an audit ready state of review by sponsor, Regulatory or Auditors
• Key point of contact for the Clinical team and other line functions on day to day study data issues, eCRF design, edit checks, and other implemented components.
• Organize and lead regular DM team meetings to provide an update for trial status, metrics, discuss study milestones and trial related issues.
• Actively participated in study kick off meetings to plan and discuss lock timelines.
• Delegate data review, data reconciliation and query management tasks to assigned data managers. To also, review and ensure the quality of work completed by the resources.
• Review the activity and progress of team members who have been delegated activities.
• Improved communication between departments through regular status updates and issue resolution meetings, leading to smoother project progression.
• Have imparted class room trainings and mentored Data Management Associates on process and data management activities enabling faster onboarding of the team members.
• Evaluated vendor performance and provided feedback, contributing to stronger partnerships and better service delivery.
• Efficient collaboration with the team from Shared Services to ensure timely deliverables with high quality.
• Oversee and manage the activities of the outsourced trials including QC of the ongoing work and keeping a check on its progress.

• Cardiovascular
• Diabetes
• Rheumatoid Arthritis
• Infectious Diseases
• Vaccines
• Oncology

• OC-OC-RDC
• InForm
• Viedoc
• RAVE

• Title: Clinical Data Management
• Date of Birth: 04/10/86
• Gender: Female
• Marital Status: Married

• Pallavi Sardesai, Sr. Principal Clinical Data Manager, Novartis, India, pallavi.sardesai@novartis.com, +91-888-6487-789