Posted 3 months ago
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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