Opportunity : While the clinical trials industry has grown over 400% in the past 10 years, 80% of clinical trials fail to finish on time, resulting in lost revenue that can range from $600K- $8M a day. Inefficiencies in the clinical trial process lead to missed deadlines, failed audits, and high Clinical Research Associate (CRA) turnover (nearly 30% in 2018) due to stress and fatigue.Our Solution :On-Time Trials (OTT) is a first-of-its-kind practical SaaS solution that helps Sponsors & CROs accelerate the clinical trials process which enables Sponsors to launch drugs & devices faster or fail faster and redeploy resources.

Director of Engineering & Operations.

Responsible for designing and setting up a Lean - PMO office for worldwide operations. Piloting with various clients Global Marketing team with impressive results. Currently mentoring a team of 6 Project leads at various clients and a team of 7 ELOQUA developers / architects in India with 100% success rate on Project delivery YTD. Successfully introduced Demand Capacity Models, Project Planning and Scoping, SIPOC (Input / Output), VSM, and X – Matrix –HOSHIN planning to Client and Verticurl teams. I also advise the SMT on Operations and Lean PMO best practice.

Responsible for Cost, Delivery & Quality of rugged Tablets and Docks built by ODM Partner in Taiwan Designed a near to real-time Delivery reporting tool based on Lean principles to track Ship to Commit (STC) and Ship to STD Lead time. The Pull reporting tool highlighted potential operational risks in near to real time and permitted rapid tactical action plans to resolve issue. Results: Brought STC from 18% in Jan to 100% May and ST STD LT from 42% in Jan to 100% in May.

Results driven business improvement executive / consultant with 18 years of driving improvement in multiple industries on an international scale. Offer consistent record of success transforming teams to deliver value to the customer at the right time with the right quantity and in the right way. Confidently builds, leads and empowers the next generation of process improvement change agents to ensure sustainability and sharing of best practices across the value chain whilst positively invigorating the culture along the way. Known as an innovative strategist that helps enterprises achieve consensus and alignment from boardroom to the front line and expertly develops tactical cascading KPI scorecards that correlate to bottom line. Demonstrate not only in-depth technical knowledge but also strong communication, problem-solving and crisis management abilities.

Responsible for : - Lean-Sigma Training design and Delivery to Clinical Trials Management.- Facilitate Strategic Planning with Group President.- Act as internal MBB consultant to various teams.- Designed and Built MS Excel Macro based Headcount Capacity Model based on IE Principles.- Participate in Future state design concepts for Clinical Research monitoring.- Provide input for Articles to Corporate communication to promote best practices.

Pricing Process Redesign : Designed a process to improve the clients ability to make pricing changes to their Online store.

Lean Training Program: Successfully designed a lean training program specific for the Clinical trials Industry. FMEA Consultancy : Provided FMEA consultancy for their process leads prior to Technology review.

Lean Operations : Provided Operations training and mentoring to the Senior Management, Sales and Service teams. I helped these teams to develop their own Demand / Capacity models and to identify opportunities through demand workflow, improved team flexibility, improved Input and output quality via SIPOC analysis, reduction of NVA work content and Value Stream Mapping. Strategic Development: Introduced the Executives of the company to the ‘’X- Matrix’’ Strategic development planning system. The X-matrix strategic planning system ensures all levels of the organization are integrated and aligned

Lean – Sigma Mentoring: Provided Lean-Sigma mentoring to NI Continuous Improvement teams. Teams ranged from Marketing, IT (E-Commerce & Applications), Research & Development, Quality Engineering, New Product Introduction, Manufacturing, Customer Support, Service Returns and Customer Integration. I helped the teams to internalize the benefits of Lean-Sigma and select the right tools to reduce variation and favorable mean shift in performance.

Protocol Owner Pull System Pilot Project : Created an excel based protocol planning tool based on Lean principles. The pilot is has highlighted huge opportunities to reduce Protocol Cycle time by at least 10%. Also working on Designing an IT Protocol Planning System using FMEA design methodology.Operation Fundamentals : Provided Operations / fundamentals training and mentoring to the Clinical trials Site selection team and the Monitoring team’s. I helped these teams to develop their own Demand / Capacity models and to identify opportunities through demand workflow, Improved team flexibility, Improve Input and output Quality via SIPOC analysis, reduce NVA work content via EAR (Expertise Applied Ratio) and Value Stream MappingProcess Assessment : Successfully completed a 4 month Operational assessment of the organizations Clinical Trials process. The following Lean-Sigma tools were used: Demand / Capacity Analysis, Work flow / Process Mapping, SIPOC’s, VA-NVA Analysis and Value stream Maps. The project concluded with some recommendations that were presented to the management team.

Credit Review Demand Reduction Program : The Mgt at the bank had planned to reduce headcount by 30% in Jan 2010. The project goal for the team was to identify area’s to streamline the process so that the reduced workforce could cope with the demand.The project was very exciting and fast paced where we did VSM on the ‘’As Is’’ process, Identified CTX metrics, ran Kaizen events centered on the TPS A3 process to create the ‘’Future State’’ VSM.Projects identified reduced demand by 35%. These projects were implemented in December 09.

X- Matrix strategic planning and training and mentoring Lean Sigma change agents in Operation fundamentals, LEAN & Six Sigma.

We have simplified the complexities of Lean and Six Sigma so that it can be deployed to any Organization.We offer a hands on approach to coaching and consulting that simplifies the complexities of Lean and Six Sigma. We introduce organizations to the very successful ‘’X-Matrix’’ strategic planning system that ensures all levels of the organization are integrated and aligned. This approach ensures savings are real and will successfully contribute to the bottom line. Breakthrough Consulting method’s will deliver big savings as it’s strategy focuses on three simple factors:- Effective Leadership.- Choosing the right Improvement strategy.- Creating an Infrastructure that ensures sustainability and growth.

Master black belt to BZWBK Six sigma team's. Also facilitated benchmarking and strategic planning using x-matrix technique

Snr Mgr of Op's Excellence team where I ran Six Sigma and LEAN programs and mentored Green and Black belt's. I also led Dell's first TOYOTA Production system on their server line of Products.

I was a program Manager at Dell where I ran many Engineering related initiatives related to improving the customer experience and innovative solutions to increase plant capacity and improve productivity. I was responsibe for leading a team and creating the vision in designing and implementing a 5 sigma process where we outsourced the back end manufacturing process. The project was called Doc 01 and was a complete success where we used Six /sigma techniques to implement a repeatable and reproducable process. This project led to my re-location to DELL's HQ in the US.

Start up Company manufacturing Interior trim products for Volvo. I was responsible for the manufacturing design and implementation of a Toyota Production System. The project was an absolute success where we designed machines with In process quality POKE-YOKE, based on load and walk away principles within a takt time of 29 sec's. We also were very strong on Employee involvement and had excellent Kaizen , SMED, 5'S programs in place.