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

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