JVT Advisors

Lead BA, Clinical Informatics

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length: 6+ months

Job Summary: 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.

 

Responsibilities:

  • Partner with clinical operations, data management, biostats, clinical supplies organization, medical affairs, regulatory and safety to execute on 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.

Requirements:

  • Bachelor's degree in Computer Science, Biotechnology or equivalent required. Master's preferred.
  • 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
  • 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

 


 

Chintan “Calvin” Raval

Vendor Operations Manager/Senior Recruiter

As the vendor manager for the Contract Recruiting team, Chintan is responsible for contract negotiation, continuing to expand relationships with IT service providers, and functional reporting including metrics for billability, operational issues, and investigated root causes.

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