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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.
- 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 analysts 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.
- Proven efficiency in conflict management, influencing and negotiating skills with the ability to lead or manage stakeholders effectively.
- Deep Domain knowledge and work experience in areas of virtual trials, clinical trial process, real world data, research studies, site payment management, clinical trial audits/ monitoring, clinical trial management technology and data.
- 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
