Job Title: Lead Clinical BA
Location: Remote until Covid then Cambridge, MA
(Client is open for 100% remote too but try to look for locals or near-by candidates who can go on-site for meetings.)
Duration: 6+ months contract
Independents with LinkedIn
Job description:
This role is an exciting opportunity to be a critical part of Moderna’s growing Clinical and Medical Digital Systems Team, supporting a high-growth organization that is radically changing the biotech industry.
Reporting to the AD, Clinical and Medical Digital Systems, the Business Analyst will support the requirement gathering and implementation of Clinical and Medical Digital systems.
Here’s What You’ll Do:
- Partner with clinical operations, data management, biostats, clinical supplies organization, medical affairs, regulatory and safety to execute on Moderna leading edge digital and analytics strategy to support accelerated drug development.
- Collaborate with business stakeholders across clinical operations, drug supply, patient recruitment, biosample management and regulatory business units to understand their current and future state goals and objectives from a global perspective in a high growth fast-paced environment.
- Lead user centered design workshops for the collection and refinement of personas, epics and user stories.
- Influence stakeholders and work closely with them to determine acceptable solutions.
- 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
- Author requirement documents: epics, user stories and associated functional and design documents
- Assist in the authoring of validation artifacts for user acceptance testing and procedural documents (SOPs)
- Support product owners in product backlog grooming and release definition
- Organize sustainable and scalable support processes to delight your customers
- Here’s What You’ll Bring to the Table:
- 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 pace 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.