Massachusetts Jobs

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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