• Us Citizen

• Green Card

• EAD (OPT/CPT/GC/H4)

• H1B Work Permit

• Corp-Corp

• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 6th Jul 2021

·         Fundamentally you are a business analyst who enjoys interacting with your end users and can drive product definition and execution in a fast-moving digital organization. You understand and practice lean and user centered design methodology. You are passionate about drug development and bringing new medicines to patients.

·         At least 5 years’ experience in the definition, design, implementation, and support of solutions in one or multiple clinical and medical systems:

·         CTMS, IRT/IWRS, EDC

·         Veeva Clinical Vault (CTMS, eTMF, SSU etc.)

·         Clinical data warehouse

·         Clinical operations data warehouse

·         Site engagement portals

·         Decentralized trials platforms

·         You have a proven experience with external vendor integration (CRO, central labs, imaging labs etc.) and vendor technology management.

·         Experience with Computerized System Validation and global regulatory requirements for data privacy and protection (GDPR).

·         Tangible track record in using Agile approaches for product development.

·         Demonstrable experience in Design Thinking.

·         Working knowledge of cloud-based requirement management and agile process management tools (Jira, Confluence, Asana or similar)

·         As a technologist, you know your craft and, you are fluent in the digital world. You have first-hand knowledge of technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials.

·         You have a working knowledge of clinical operations, clinical data management, regulatory and safety business processes in a drug development context.

·         You work independently yet engage proactively with team members, colleagues, and stakeholders to get alignment and drive projects forward.

·         You don't hesitate to dive in and work alongside the team. You can effectively manage conflicting priorities in a fast-paced environment, and you can navigate ambiguity effectively.

·         You put team before tasks by collaborating actively with all team members and supporting them.

·         A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

·         Bachelor's degree in Computer Science, Biotechnology or equivalent required. Master's preferred.