VIJAY SHANKAR RAJ MN

PointCross Life Sciences is a technology solutions provider for the Life Sciences industry, offering a powerful commercial off-the-shelf (COTS) platform—Xbiom™—for Clinical and Nonclinical Interim Study Monitoring, Data Ingestion, Visualization, Cross-study Analytics, and Centralized Data Repository. PointCross supports sponsor and CRO clients, including global pharma companies and regulatory agencies, by aligning data workflows with CDISC SEND/SDTM compliance.

Key Responsibilities & Leadership:

• Directed enterprise solution deployments for pharma clients including Roche, FDA, Sanofi, Ipsen, BMS, and Novo Nordisk—overseeing a globally distributed team (>100).
• Consulted on IT gap assessments, compliance strategies, and regulatory readiness in alignment with CDISC SEND, SDTM, and regulatory SOPs.
• Drove PointCross’s product architecture and roadmap strategy, interfacing with US, EU, and India-based executives and developers.
• Managed PointCross’s flagship Xbiom™ Suite product line—facilitating LIMS integration, data normalization, and analytics for Clinical and Nonclinical domains.
• Anchored FDA NIMS deployment aligned with HHS EPLC framework; led CRADA initiative with FDA NCTR for SEND support development.
• Designed and executed the turnkey Clinical and Nonclinical Validator Specifications to support regulatory data review and submission readiness.

Product Management Highlights – Xbiom™ Suite:

• Oversaw development and delivery of modules for:
• Controlled Terminology Mapping
• Historical Control Reference Range Analytics
• Reprotoxicology and PK/TK Data Visualization
• SEND & SDTM Validator and Study Repository Tools
• Enabled integration with 15+ industry standard LIMS systems (Sponsor & CRO) into the Xbiom platform.
• Contributed to CDISC SEND working groups and piloted visual analytics for reviewers (IGO tool) with FDA and sponsors.

Key Achievements:

• Roche SDI Project: Delivered an integrated data repository for over 8,000 studies after two prior vendor failures—earning long-term client trust.
• Sanofi Pilot to Contract Conversion: Successfully executed proof-of-concept that secured a multimillion-dollar contract.
• Pharma Delivery Scale-Up: Led a strategic staffing and skilling initiative resulting in a 300% expansion of the pharma delivery team.
• Industry Thought Leadership: Conducted client webinars, developed RFP responses, SOWs, SLAs, and supported new business acquisition.

Joined the firm which was a start-up venture and spearheaded the growth & development of the work place for Service business. Was instrumental in setting up the entire organization structure and played a pivotal role in engaging the best of talents from across the industry. As Head of HR & Admin, my core responsibilities included providing strategic inputs to the Managing Director and Heads of corporate functions & ensure that business and people plans are integrated across the business unit and that HR policies & processes are mapped to support the growth of the business.

Key Achievements:

• Conceptualization HR - setting up strategic key functions of Human Resource Process Design & Development
• Support the MD on strategic initiatives and to develop the various functions by defining the right structure & profile and hire the right teams.
• Responsible for Talent acquisition activities right from Man power planning, forecasting, periodical validation, coordination with unit/project managers on strategies for sourcing, negotiating and selection of resources in various departments / functions as per the requirements, Induction and on-boarding.
• Designing and implementing Compensation & Benefits plan in line with current Industry & market practices.
• Policy creation & Process mapping in line with changing organizational needs.
• Partner with business on organizational design, workforce planning, succession planning, and skills assessment.
• Play the role of a HR consultant to the business on aspects of organizational structure, compensation & benefits and employee management.
• Work closely with business leadership on people management issues and help resolve them.
• Building leadership capability, organizational capability and culture to win in the market place.
• Performance management system- Design, manage & drive processes and support culture relating to mentoring, counseling, goal setting, performance feedback, and career planning .
• Employee retention, Succession planning & Talent management.
• Employee welfare & communication.
• Responsible for safety, security & transportation at the corporate & Site offices.

I was reporting to the Manager HR and was responsible for providing HR leadership and consultation to business leaders and line managers on strategic and people related matters. I was responsible for managing Human capital for both in-house as well the customers, comprising of more than 250 employees spread across 3 major customers have strived to create a high engagement culture through my contribution to Talent management, Employee engagement, Performance Management, Organizational Development, Change Management, HR operations, People/process & culture Transitioning), Internal Audits & Communication.

Key Achievements:

• Seamless HR Engagement right thru talent planning, acquisition, Induction, Employee life cycle management, employee relations, learning & development.
• Partner with international HR & OD teams to support business unit initiatives & roll out of HR Initiatives and OD interventions including conducting of Assessment centres & development centres.
• Play the role of a HR Business Partner to the functional heads in the regions on aspects of Regional business structure, compensation & benefits, employee engagement and retention strategies.
• Lead capability building process to meet present and future capability needs to help the
  business remain competitive.
• Manage the implementation of CDL which include - providing relevant inputs to help identify the potential 'Talents', assess the profiles of these potential 'Talents' by doing an extended interview and collate information for the 'Talent Review', organize the 'Talent Review' and provide valid inputs on development plan for the Talent’s progress and eventually support the management in implementation & monitoring of the Individual development Plans.
• Championed development of Leadership via Development and Assessment Centers.
• Compensation & Benefits- Provide compensation support including salary planning, approval of salary actions, promotions, Job evaluation, Job grading and job re-leveling.
• Performance management-Managed the entire performance management cycle pan India, right from designing the appraisal forms, compiling the ratings and rationalising the same for management review, getting the required approvals and rolling out the increment & bonus letters to the employees.
• Regional Shared Services - Point of contact for all operational activities in the regions including Headcount budgeting & tracking, Rolling out offers, On-boarding, Confirmations, Generation of various reports – Employee master, new employee database, Attrition reports, Internal employee transfer reports, Exit formalities, Employee help desk etc.
• Audit, Risk & reviews- Conducting periodic internal audits to assess compliance, evaluate risks and review with the teams on corrective actions.
• Learning & Development- responsible for chalking out the training and developmental needs of the employees in consultation with the business heads.

Was employed with SAP India Ltd in consulting Business unit in Bangalore. As a Consultant -Human resources, I was reporting to the Head – HR & was responsible for independently managing the entire gamut of Human Resources & Administration of over 200 employees.

As a Intern I was mainly into supporting the Strategic Resourcing Team in the various recruitment activities like Campus and Off-campus recruitment activities & selecting the candidates