Prajakta Prakash Desai

Contact No.: +919********* [M]

E-Mail: adizlz@r.postjobfree.com

Synopsis

A promising data manager with more than 8 years of experience in Clinical Data Management domain. Proficient in the use of EDC systems, database design, collecting and analyzing clinical data, database lock. Academia

• Master of Science in Clinical Trials and Drug Development Data Management from Dibrugarh University in August 2012.

• Bachelor of Science in Biotechnology from Mumbai University in April 2010.

• Internship at JM Services Company Pvt. Ltd. (Quintiles). Professional Experience

PPD (Pharmaceutical Product Development) (Sep-2020 to present) Clinical Data Team Lead

Therapeutic Areas: - Infectious Disease (COVID-19 Vaccine), Parkinson’s Disease, Oncology Database and Tools: - RAVE 5.6.4, RAVE X

Key Responsibilities: -

• Acts as an interdepartmental and client liaison for all DM study activities for the assigned projects.

• Produces project-specific status reports for management, PM and/or clients on a regular basis.

• Monitors and analyzes study metrics and escalates per the organization’s risk management processes.

• Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks.

• Assists with project forecasting of hours and identification of resource requirements.

• Independently leads and delegates tasks to ensure timely completion of project activities to project timelines, quality, and budget.

• Mentors team members on all associated tasks within a study.

• Communicates with management regarding all data management activities within their studies.

• Currently handling studies in set-up and conduct phase.

• Presented DM scope and activities in Investigator Meeting. Tata Consultancy Services, Mumbai (Jan-2015 to Aug-2020) Business Process Lead

Therapeutic Areas: - Oncology and Respiratory

Database and Tools: RAVE 5.6.4, J-Review, BOXI, BO4 Key Responsibilities: -

• Study Data Lead role on multiple studies and a primary contact for client from the data management team.

• Responsible for communicating with client on an ongoing basis, taking up teleconferences for the study, providing study status updates. Attended Face-to-Face Meetings in Zurich and Basel with the study teams. Presented DM scope and activities in Investigator Meeting.

• Managing a team of data managers and responsible for work allocation and performing QC on the work performed by the data managers to ensure the quality of the deliverables.

• Planning of DM deliverables and overseeing progress of clinical studies, ensuring study meet timelines, targets, and quality expectations.

• Tracking of actual efforts on the activities performed by the data managers, providing assumptions on the efforts for the new activities to the management required for budgeting and resource allocation.

• Providing training to the new colleagues on process and study related activities.

• Performed activities involved in Set up, Conduct phase and Close Out of the Trial along with the Migration activities.

• Designing eCRF, creating Data Validation Specifications (Edit checks and Custom functions specifications), Visit Matrix as per the schedule of assessments given in protocol.

• Work closely with Programmers on the design, testing and implementation of study databases.

• Interacting with Medical Monitors and CRAs to resolve data discrepancy and related issues.

• Performed Data Review, Query Management, SAE Reconciliation, External Data Reconciliation, Listing and Report generation

• Created specifications for generating listings and reports in SAS and Spotfire system. Cognizant Technology Solutions, Mumbai (Feb-2012 to Jan-2015) Junior Data Analyst

Therapeutic Areas: - Endocrinology, Hemophilia, Rheumatoid Arthritis Databases and Tools: Inform 4.6, Oracle 4.6, TOAD 9.7, OC-TMS, MedDRA, WHO DDE, ICON labs, Qnet, Clinphone, PHT Study Works

• Provided detailed Reporting and Analysis support to the client for the assigned studies.

• Communicated with Client (POC) for Reporting requirements of the studies.

• Created weekly reports to provide the details on the data cleaning activities and overall study status and data listings in the required format as and when needed.

• Generated various reports to track protocol deviations, withdrawal criteria, end points, dosing compliance.

• Designed SQL queries in TOAD to extract data from OC database.

• Received Certificate of Appreciation from the client for the excellent report set up.

• Performed Medical Coding activities on assigned project in a timely and efficient manner.

• Classification of all medical terms including adverse events, serious adverse events and medications using MedDRA and WHO DDE dictionaries respectively and coding query management.

• Performed data review to clarify and improve the quality of the data.

• Participated in Client Audit.

• Received Lean Basic Six Sigma Bronze Certification for demonstrating proficiency in deploying the Lean Six Sigma methodology and applying it to a business project using appropriate tool. Personal Skills

• Proficient in MS-Office tools such as Excel and Excel formulae, MS-Access which improves productivity, quality & time efficient performance.

• Ability to write SQL Queries.

• Ability to create simple Macros in Excel, thus reducing the time required to work on the reports.

• Training and mentoring new colleagues on data management activities and Excel functionalities.

• Willingness to learn and take up new responsibilities, Disciplined and methodical.

• Effective Time management.

Awards & Recognition

• Star Performer Award from Client, Internal On the spot, Star Performer and Service and Commitment Awards from TCS.

• Certificate of Appreciation from Client in recognition of exemplary performance & valuable contribution to the project, Trailblazer award for outstanding performance, productivity, and dedicated service from Cognizant.

Personal Dossier

Date of Birth: 10th July 1989

Gender: Female

Marital Status: Single

Languages Known: English, Hindi, and Marathi.

Address: A-404, Sai Mangal Society, Eksar Road, Borivali (West), Mumbai- 400092, Maharashtra, India. Nationality: Indian.

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