The Role:
- Partner with clinical operations, data management, biostats, clinical supplies organization, medical affairs, regulatory and safety to execute on our leading edge digital and analytics strategy to support accelerated drug development.
- Business analysis and system support for clinical operations, drug supply, patient recruitment, biosample management and regulatory business units in a high growth fast-paced environment.
- Lead user centered design workshops for the collection and refinement of user requirements
- Collaborate with data engineering, informatics and data science team to develop modern analytics applications
- Engage with digital integration engineering team, business and quality systems teams to implement cross-functional integrations and support our digital integrated landscape
- Prototype analytics applications to support data stories and support user testing activities as part of application release cycle
- Author requirement documents: epic, user stories and associated functional and design documents
- Author and manage testing artifacts to support product releases
- Support product owners in product backlog grooming and releases definition
- Organize sustainable and scalable support processes to delight your customers
- Fundamentally you are a business systems analyst who enjoys interacting with your end users and can drive products 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 analytics solutions across the following Clinical Systems
- Legacy CTMS (Impact, Siebel)
- 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
- You exhibit deep understanding of clinical development operational metrics and key performance indicators.
- Experience with Computerized System Validation and global regulatory requirements for data privacy and protection (GDPR)
- You have a basic understanding of advanced analytics concepts (AI/ML) and the application if data science to clinical data
- Tangible track record in using Agile approaches for product development
- 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 pace environment, and you can navigate ambiguity effectively.
- You put team before tasks by collaborating actively with all team members and supporting them.
- Bachelor's degree in Computer Science, Biotechnology or equivalent required. Master's preferred.