Yogesh Dalvi

About Yogesh Dalvi

I have experienced in Clinical Research Professional.I have an in-depth exposure to a wide spectrum of activities associated with the various CLINICAL TRIALS (Phase I, II, IV) catering to various regulatory body. Along with that I also have experience in Clinical Research industry I have around 8 YEARS OF EXPERIENCE IN CLINICAL RESEARCH INDUSTRY.I like to work in a dynamic, challenging environment, and to significantly contribute to the organization’s objective, this will help me to grow along with the organization and undertake challenging assignments for learning new things. I have performed Activities in conduct and Closeout. I would want to work hard in Clinical research industry and contribute to society in terms of healthcare and gain expertise in personal and professional front. Good Experience of Clinical Data Management.

Experience

1. Senior Clinical Data Management Scientist

   Accenture in India

   Aug 2022 — Present

   At Accenture currently working as PDM•For Study meeting preparing slides for DQST and Global team meeting with entire study Data Management Status; Monitors and communicates, escalating project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection for missing pages, query status, Uncoded terms, pending SDV /PI sign, Freeze/Lock form status, External Data issues, SAE Reconciliation, Subject Status, PDRP review etc.• Coordinate and allocate the work of the assigned Data Management• Timeline preparation for PPC/Migration, Final DBL for various study and meeting timeline with quality.Ensures launch, delivery and completion of all Data Management activities and milestones like Migration, Final DBL, CPG, Survival Sweep according to agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations• Worked on PDM Listing Review, Audit Trail Review, DRA Filling,Unlock/Unfreeze request, Tracking follow up with site facing roles CTM via metrics etc.• Provides project specific training, various task to DM team as and when required, Plan, manages and requests resources for assigned projects• Preparing of study documents like eCCG,PDRP,DQMP,• Trains and mentors data management staff on various study required or any new allocatio • Maintains all documentation on an ongoing basis and ensures that all TMF filing is complete and up to date and perform eTMF QC.• Participates in, and presents at internal DQST, Sponsor-Global Team Meeting, third-party meeting,PDM DM meeting, DML PDM meeting on weekly or monthly,ad hoc basis.Preparing MOM and documenting decision in Action and Decesion log• Site closure activity as per site closure tracker and sending PDR to sites after Closeout/Final DBL• Ability to make effective decisions and manage multiple priorities.• Strong project management skills and knowledge of project management methodologies• Ability to be flexible

Education

• Birla College of Arts Science & Commerce Birla College Road Kalyan Dist Thane 421 304

  Bachelor of Science - BSc

  2006 — 2009

• Ramnarain Ruia College

  Master of Science - MSc

  2009 — 2011