Life Sciences Management Consultant - Clinical Research & R&D

Infosys; Bengaluru; On-site; INR 3,000,000 - 5,400,000; Full time

Job summary

Infosys Life Sciences is seeking an experienced Life Sciences Management Consultant (8–10 years) to join as Consultant/Senior Consultant. The role focuses on Clinical Data Management and Clinical Trial Operations, including EDC, eTMF, CTMS and SSU.

You will translate business requirements into technical specifications, lead agile delivery, and engage client stakeholders while driving digital capabilities for pharma/biotech clients.

Qualifications

• 8–10 years of experience in R&D Clinical Research as Consultant/Senior Consultant.
• Practical experience in Clinical Data Management and Trial Operations.
• Deep knowledge of EDC, eTMF, CTMS and SSU systems and processes.

Responsibilities

• Analyze and translate business requirements into technical specifications for delivery.
• Facilitate integration of EDC, eTMF, CTMS, and SSU to streamline operations.
• Lead agile projects across the life sciences value chain and ensure delivery quality.
• Engage client stakeholders, identify opportunities, and support business development.
• Lead and support initiatives, SOPs, and working practice guidance.

Skills

Requirements analysis

Cross-functional collaboration

Agile delivery

Stakeholder management

Client engagement

Solution architecture

Digital transformation

Life sciences domain

Tools

EDC

eTMF

CTMS

SSU

VeeVa

Medidata RAVE

Oracle

Job description

Life Sciences Management Consultant

We are looking for 8-10 years experienced RnD Clinical Research professionals as Consultant/ Senior Consultant to join our team as a Techno-Functional Business Analyst. The ideal candidate should possess practical experience and in-depth knowledge of Clinical Data Management and Clinical Trial Operations, including Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), Clinical Trial Management System (CTMS), and Study Start-Up (SSU).

• Analyze and translate business requirements into technical specifications. Collaborate with cross-functional teams to implement and optimize Modules.
• Facilitate the integration of EDC, eTMF, CTMS, and SSU systems to streamline clinical trial operations. Demonstrate excellent core competence and experience in delivery of agile projects using scrum or various other methodologies across value chain in Life Sciences
• Industry experiences working directly at Consulting organization for pharmaceutical, medical devices or Bio- pharmaceutical clients is a plus.
• Proficiency with IT tools supporting delivery CDM - VeeVa, Medidata RAVE, Oracle etc Manage program planning, execution and reporting, responsible for program resources, Deliverables, Quality, Stakeholder communication, Client Buy-in, program risks, mitigations and budgets leading to successful program delivery and client delight.
• Understand areas of concerns for a Pharma Organization and being able to suggest Innovative ideas to improve their existing processes
• Lead and support initiatives for the improvement initiatives, organizational SOPs, working practice guidance documents.
• Engage and maintain contacts with key client stakeholders, proactively identifies opportunities for business development.
• Lead sales pursuits in collaboration with Larger Infosys teams, Lead proposal development process, solution formulation, Proposal pricing, client presentations, contract negotiations and deal closure
• Develop solutions that enable adoption of digital capabilities for life sciences organizations.

Participate in analyst's meetings, industry speaking engagements, publish white papers in leading industry journals

• Participate in practice development activities, coach consultants, participate in consultant training and staffing process.