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Sr. BA - Clinical operations

Princeton, NJ, United StatesRemoteContract

AI Summary

Senior Business Analyst supporting clinical operations for Otsuka, involved in end-to-end clinical trial management and bridging business needs with technical solutions.

About this role

Sr. BA - Clinical operations

Client: Otsuka Sr. BA

Location: On-site Princeton, NJ. Should be able to travel to Rockville, MD

Duration: 3 to 6 months

  • 9-11 years of experience in a pharmaceutical company/CRO with business analyst along with project management
  • Strong understanding/knowledge on clinical research and development area with regulatory documentation
  • Strong understanding of clinical, data management, safety and regulatory IT systems such as CDMS (EDC), CTMS, eTMF, RBM, IVRS, Safety, Regulatory submission and publishing systems
  • Experience in end-to-end (full service) clinical trials management, ideally with project management relevant clinical research experience
  • Understanding of various business groups and their functions tied to clinical drug development
  • Experience to understand and come up plan to fill the gap between business process and technologists
  • Should be aware of end to end clinical business and technical process
  • Should be able to take a problem statement and do industry research. Come up with options / solutions available. Should be able to draft RFI/RFP – and Lead them
  • Bring in best practices for BAs.
  • Should be very good in business case preparation, road mapping etc
  • Should have experience as a business process consultant.
  • Very proactive, motivational, and can work independently
  • Ability to understand large complex processes with a focus on continuous improvement
  • Strong technical writing skills and analytical skills
  • Strong networking abilities and an ability/willingness to work with individuals globally

Additional Information

All your information will be kept confidential according to EEO guidelines.

Skills

CDMsCTMSEDCETMFIVRSPublishing SystemsRBMRegulatory Submission SystemsRFIRFPSafety Systems

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