Souvik Bit Email & Phone Number

Waltham, Massachusetts, Us

Head of Service Delivery for Safety systems. In-Depth knowledge around Driving Organizational operational goals around EBITDA, Quality, CSAT and Delivery Excellence. Spearheading large scale and Multi million SaaS safety implementation deals. On premise to Cloud transformations. Building High Performance Teams, Setting up operational delivery processes and governance for large multi-million dollar accounts are my core strengths. Very passionate and have proven results towards building organizations around motivated young talent pool and creating an ecosystem that promotes "culture-of-growth"

Durham, North Carolina, Us

Program Director RWTS Registry Practice

Durham, North Carolina, Us

Delivery Lead for multi-million dollar account deliveries from India with an approx. 100 member team for the registry practice EDC program KPIs for delivery lead include career planning and annual reviews, compensation planning, EBITDA targets and gains, Strategic discussions and key leadership governance discussions Represent India Senior leadership for the Registry program Key stakeholder within the leadership team for communications and escalation management

Durham, North Carolina, Us

Proven track record in heading various systems according to business needs (as-is & to-be analysis) and reviewing process flow as per the specifications.Expertise in directing cross-functional teams by using interactive and motivational leadership skills with an equal desire to win.Leveraged skills in performing functions entailing Clinical Data Management / Vendor / Contract Management, Custom product configuration deliveries, COTS Electronic Data Capture (EDC) Product Integration.Comprehensive knowledge of EDC products like Inform, Rave & Infosario Outcome, Clinical Trial Data Management for Phase I,II,III & Phase IV Clinical Research Trial, Electronic Patient Reported Outcomes, Pharmacokinetic and Pharmacodynamic clinical trial configurations, EDC driven Pharmacovigilance, 21 CFR Part 11 & GxP Standard based electronic data management Accountability for the compete technical project management function for EDC program Delivery Center in Bangalore Lead a team of 15 Project Managers including their career planning and appraisals Accountable for Managing Leadership communications in terms of Monthly Reviews of the project management function Administering Real world late phase observational study in terms of EDC product implementation for key pharma and healthcare customers Represented ‘EDC Product SME’ across the complete function and participating in RFPs

Durham, North Carolina, Us

Acted as one of the Key Project manager across complete real world late phase observational studies and EDC implementation for several sponsor projects using Agile scrum delivery framework Worked as ‘Product Manager’ and coordinated EDC implementations across various customers Supervised a cross-functional project teams from Business Development, System Analyst, Data Manager, Developer, Software Quality Analyst, Technical Support and Production Service Manager Administered functions related to identification of resources for each configuration releases, development of documentation template for project planning, execution of best practices with project management functions, technical requirements gathering process for EDC systems

Noida, Uttar Pradesh, In

Presently working on a large application Decommissioning project for one of the Pharmaceutical Majors in Europe.Responsible for End to End project management and I am involved in project estimations, service delivery planning and scheduling, resource management and Contract Scope management.I am responsible for managing resources from both HCL and Vendor Companies from Onsite and Offshore locations.I am involved in negotiations of contracts and closing dealsSingle point for contact for project service delivery, Vendor and contract Management, Demand and relationship Management and coordinating the invoicing and BR processes.

Noida, Uttar Pradesh, In

Was working as a Project Lead for various projects in Clinical Trial Space for one of the large pharmaceutical major in the world. I was responsible for ensuring smooth services delivery in Preclinical, Clinical, safety and regulatory business areas within the Client organization. I worked closely with client stakeholders in understanding their requirements and aligning project teams to deliver services to meet customer satisfaction. Was responsible for coordination of onsite and Offshore Teams and aligning the resources of the project team to provide 24*7 support model for the Client Business Processes. I was responsible to work with project teams that involved delivering of production support to Client processes to make sure that all appropriate SLA levels are being achieved. I was responsible for coordinating the Incident, Problem and Change management processes. I was responsible for proper escalation management and performing Root cause analysis for any service Disruptions. I was responsible for collaborating with project Teams to make sure that the Business and technical requirements/solutions are well aligned with customer expectations. Was responsible to ensure that the quality of deliverables were as per the expected Client standards and overall project met HCL Goal Metrics

Worked onsite(US) as a Business Analyst for Phase I and Phase II Clinical trial studies for one of the largest Pharmaceutical companies in the world. Was involved in Study structuring, identification of protocol challenges, collector development for phase I clinical trials on European and North American sites. Was involved in understanding of clinical trials business requirements, identification of various technological advancements related to applications and tools in Clinical trial space, Clinical Trials related data management and various levels of data analysis and troubleshooting within legacy group of trial management applications. I was a liaison among project stakeholders for eliciting, analyzing, communicating and validating requirements for changes to business processes involving technology. I was responsible for translating Business requirements from Clinical trial study protocols to functional specifications for configuring metadata and deploying collectors for capturing Clinical trial data. I was responsible for providing End user support and troubleshoot production systems using my strong technical and problem solving skills. I was responsible for coordination of the onsite and offshore teams for delivering services to client in a timely manner. Had executed roles of Defect Prevention Analyst(DPA) and Project Quality Assurance(PQA) for these projects

Noida, Uttar Pradesh, In

Worked as a key stakeholder for the PMO for Customer at HCL, Location. Briefed directly to Business Unit head of Customer at HCL. Was handling the billing and invoicing of the integrated Customer account at HCL. Directly reported to both Delivery and Sales head of Merck account at HCL and was engaged in preparation of major Senior Management Review presentations, Metrics Monitoring, Resource Movements, Tracking of new business opportunities, Cross functional interactions between various stakeholders within the management organization, Client level status report presentations, Requirement gathering for any RFPs, skill wise capability building, Knowledge and Document management and Quality management. I was involved in making Engagement Case studies, White papers and collaterals. At Client Relationship level, PMO was single point of contact for contract management, financial management, metrics management and customer relationship management and being a major stakeholder of PMO, I had played a major role in these areas as well. I had executed a Six Sigma project for optimization of the billing process which was routed through the PMO and the was awarded the Six Sigma Green Belt certification for the process improvement and Dollar savings

Noida, Uttar Pradesh, In

Reliance Lifesciences Pvt Ltd: As a Management trainee I was involved in prelaunch Market Analysis and Survey for a New Product Launch. I was involved in analyzing different phases of Product Lifecycle (PLC).Survey methodology adopted was questionnaires and personal interview with the end users(doctors) of the high end hospitals gathering requirements on the different aspects of the new product.

Master Of Business Administration - Mba, International Marketing

Mba

B.Sc(H), Biotechnology

10+2, Science