Sanjay Mondal

About Sanjay Mondal

With over 20 years of experience in the CRO and ITES industries, I have led large global FSP, EDC, and clinical programming organizations, driving operational excellence and strategic growth. My leadership spans end to end project delivery, global client engagement, risk management, talent strategy, and the establishment of enterprise performance frameworks. I specialize in building high performing teams, scaling operations, and guiding complex programs to successful outcomes.As a PMP® and Six Sigma Green Belt (SSGB), I bring a strong foundation in quality, compliance, and process optimization. My expertise covers multiple EDC and advanced analytics platforms, enabling me to design and implement innovative, technology enabled solutions that improve efficiency and accelerate timelines. I have partnered with leading global pharmaceutical and biotech organizations, delivering domain specific strategies that address complex regulatory, operational, and data driven challenges.Key Skillsets:• PMP and Six Sigma Green Belt certified, with hands on experience driving Agile project execution and organizational efficiency• Directed operations across Visual Analytics, SAS, Power BI, EDC, and IRT/eCOA technologies, ensuring high quality delivery for large, complex portfolios• Expert in Medidata Rave (SME, Study Designer certified) with extensive knowledge of core Rave modules, integrations, coding workflows, and database lifecycle management also trained in Oracle InForm and Merge eCOS• Played pivotal role in bid meetings, capability presentations, and strategic business conversations with clients to support growth and partnerships• Led workforce planning, recruitment, mentoring, and capability development programs, strengthening technical expertise across programming groups• Developed innovative solutions, KPI dashboards, and productivity measurements to enhance delivery quality, automate workflows, and reduce manual effort

Experience

1. Associate Director, Clinical Programming

   Fortrea

   Jul 2023 — Present · IN

   Job Responsibilities:o Oversee day to day operations of EDC database design and Clinical Data Insights teams.o Create management dashboards to showcase project health score in the areas of – Resource utilization, productivity, Deliverables quality, meeting timelines.o Responsible for the hiring, training, development, utilization and performance management of a team of Programming staff. o Monitor the resources, budget and performance of the direct reports and their projects. o Support all aspects of assigned sponsor(s) and deliverables and participate in Business development presentations and bid development.o Develop and maintain close working relationship with strategic and opportunistic customers to ensure client satisfaction and operational / customer service excellence.o Maintain and review skill/career development for all direct reports.o Advise management regularly on the status and any potential risks or issues with on-going projects to ensure resolutions in a timely manner.o Track budget and scope changes, obtaining necessary client approvals for change in scope of work.o Organize, direct and coordinate planning and implementation of contracted activities including contribution to study newsletters, presentations at Investigator Meeting, Project Team training.

Education

• Anna University Chennai

  Six Sigma Green Belt, Quality Management

  2012 — 2012

• Vydehi Institute Of Biotech Sciences, Bangalore University

  Master of Science (M.Sc.), Biotechnology

  2004 — 2006

• Project Management Institute

  PMP Certification, Project Management

• Rai University, Bangalore

  MBA, Human Resources Management

  2004 — 2006

• Bangalore University

  Master's degree, Biotechnology

• Administrative Management College, Bangalore University

  B.Sc, Biotechnology

  2001 — 2004

Skills

• Edc
• Quality Management
• Quality Control
• Validation
• Clinical Data Management
• Rave Study Design
• Leadership
• Quality Assurance
• 21 Cfr Part 11
• Resource Management
• Six Sigma
• Project Management
• Management
• Team Leadership
• Team Management
• Analysis
• Business Analysis
• Testing
• Pharmaceutical Industry
• Sop
• Ms Project
• Program Management
• Visio
• Lean Six Sigma
• Standard Operating Procedure (Sop)
• U.s. Title 21 Cfr Part 11 Regulation
• Electronic Data Capture (Edc)