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.