Integrated Resources INC
Posted 113 months ago
Sr. BA - Clinical operations
Princeton, NJ, United StatesRemoteContract
AI Summary
Sr. BA - Clinical operations Client: Otsuka Sr. BALocation: On-site Princeton, NJ. Should be able to travel to Rockville, MDDuration: 3 to 6 months 9-11 years of experience in a pharmaceutical company/CRO with business analyst along with project managementStrong 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, Regul
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.