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
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