
Job Information
Randstad Business Analyst, Clinical Informatics in Cambridge, Massachusetts
Business Analyst, Clinical Informatics
job details:
location:Cambridge, MA
salary:$55 - $65 per hour
date posted:Wednesday, January 13, 2021
experience:Experienced
job type:Temporary
industry:Business Services
reference:S_876820
questions:cole.horgan@randstadusa.comDO NOT CALL
job description
Business Analyst, Clinical Informatics
Reporting to the Sr. Manager Clinical Informatics, the Buisness Analyst will support the requirement
gathering, implementation and technical support of Clinical Informatics reporting systems.
Responsibilities:
Partner with clinical operations, data management, biostats, clinical supplies organization,
medical affairs, regulatory and safety to execute on Moderna leading edge digital and
analytics stratetgy 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 requirments
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-funtional 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
Organize sustainable and scalable support processes to delight your customers
Fundamentally you are a business 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 analyics solutions across the following Clinical Systems
o Legacy CTMS (Impact, Siebel)
o IRT/IWRS
o EDC
o Veeva Clinical Vault (CTMS, eTMF, SSU etc..)
o Clinical data warehouse
o Clinical operations data warehouse
o Site engagement portals
o Decentralized trials plaforms
Qualifications:
You have a proven experience with external vendor integration (CRO, central labs,
imaging labs etc..) and vendor technology managenment
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
Other Qualifications:
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 dont 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.
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