Sr. BA - Clinical operations
IntegratedResourcesINC
Posted: February 23, 2017
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Quick Summary
The Sr. BA - Clinical operations role is responsible for managing clinical trials from start to finish, including data management, safety and regulatory IT systems, and end-to-end clinical trials management.
Required Skills
Job Description
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
All your information will be kept confidential according to EEO guidelines.