Sujeet Pingale

About Sujeet Pingale

I am a Certified Clinical Data Manager (CCDM®) and Project Management Professional (PMP®) with around 12 years of progressive experience in clinical data management across leading pharmaceutical organizations. My expertise spans end-to-end data management activities, including study setup, conduct, and closeout, ensuring high-quality deliverables across diverse therapeutic areas such as Oncology, Vaccines, Respiratory, Rare Diseases, Cardiovascular, Aneurysm, Immunology, Neurology, and Medical Devices.As an Asset Lead and Program Lead, I have successfully managed 11 projects on the sponsor side, where I implemented data management strategies, optimized processes, and ensured compliance with regulatory standards like ICH-GCP. My leadership extends to overseeing CROs and vendors, driving operational efficiencies, and mentoring cross-functional teams to achieve project objectives within scope, timeline, and budget.Key highlights of my career include: • Spearheading initiatives such as the RBS Optimization and CRF Search Engine to enhance data management efficiency using AI and NLP technologies. • Leading process improvement initiatives, vendor performance management, and strategic alignment with global regulatory standards. • Providing subject matter expertise in electronic data capture systems (Medidata RAVE, Veeva, and others) and data standardization processes. • Contributing to organizational growth by mentoring high-performing teams and driving innovation in data management operations.With a Master’s degree in Project Management from Northeastern University and a strong foundation in pharmacy, I bring a unique blend of technical expertise, leadership, and strategic thinking. My mission is to deliver high-quality, compliant data solutions that advance clinical research and improve patient outcomes.Let’s connect if you’re seeking an experienced and passionate clinical data management professional ready to drive excellence and innovation in clinical trials.

Experience

1. Associate Director, Clinical Data Management

   Eikon Therapeutics

   Jul 2025 — Present

   Provides clinical data management leadership within the study team(s) to align on and drive data collection requirements.• Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects.• Responsible for end-to-end clinical data management activities and serves as a primary point of contact cross functional team.• Provides strong quality and project oversight over third party vendor(s) responsible for data management deliverables.• Takes a leadership role to gather content and integration requirements for EDC and ensuring close collaboration/alignment with partners supporting other data collectionsystems (eCOA, External Data, RTSM, etc.). Enforces data standard conventions and ensures high quality expectations for all clinical data per defined processes & best industry practices.• Authors, reviews/revises clinical data management related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization.• Chairs Data Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness.• Represents Data Management on cross-functional project teams & submission teams.• Lead or support the Health Authority inspections and audits as relates to Data Management activities• Act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA), as required.• Define, manage and govern clinical data standards in accordance with CDASH principles and best practices.• Responsible for managing clinical data management staff, as assigned, including training, mentoring, goal setting, performance management and engagement.

Education

• SVBCP

  Master of Pharmacy, Pharmacognosy and Phytochemistry

  2010 — 2012

• NCRD's Sterling Institute of Pharmacy

  Bachelor's degree, Pharmacy

  2005 — 2009

• Northeastern University

  Master’s Degree, Project Management

  2016 — 2017

Skills

• Pharmaceutical Industry
• Phase Forward Inform
• Ich-Gcp
• Veracity Database
• Hippa
• Regulatory Affairs
• Clintrial 4.3
• Protocol
• Vendor Management
• Sas
• Microsoft Excel
• Microsoft Office
• U.s. Title 21 Cfr Part 11 Regulation
• Sql
• Pharmaceutics
• Minitab Express 17
• Critical Thinking
• Process Improvement
• Clinical Data Management
• Sae Reconciliation
• Inform 4.6
• Rave
• Good Clinical Practice (Gcp)
• Crf Design
• Eclinical Os
• Clinical Trials
• Electronic Data Capture (Edc)
• Clinical Study Design
• Project Management
• Standard Operating Procedure (Sop)
• Analytical Skills
• Drive for Success
• Clinical Research
• Data Management