Analysis Skills, Best Practices, Biotech and Pharmaceutical, Business Analysis, Business Case, Business Processes, Clinical Data Management, Clinical Research, Clinical Trial Management, Consulting, Contract Research Organization (CRO), Electronic Data Capture (EDC), Information Technology & Information Systems, Proposal Writing, Regulations, Regulatory Submissions, Request for Information (RFI), Research & Development (R&D), Technical Writing, Willing to Travel, Writing Skills
Sr. BA - Clinical OperationsClient: Otsuka Sr. BALocation: On-site Princeton, NJ. Should be able to travel to Rockville, MDDuration: 3 to 6 months9-11 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 documentationStrong understanding of clinical, data management, safety and regulatory IT systems such as CDMS (EDC), CTMS, eTMF, RBM, IVRS, Safety, Regulatory submission and publishing systemsExperience in end-to-end (full service) clinical trials management, ideally with project management relevant clinical research experienceUnderstanding of various business groups and their functions tied to clinical drug developmentExperience to understand and come up plan to fill the gap between business process and technologistsShould be aware of end to end clinical business and technical processShould 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 themBring in best practices for BAs.Should be very good in business case preparation, road mapping etcShould have experience as a business process consultant.Very proactive, motivational, and can work independentlyAbility to understand large complex processes with a focus on continuous improvementStrong technical writing skills and analytical skillsStrong networking abilities and an ability/willingness to work with individuals globallyAll your information will be kept confidential according to EEO guidelines.I
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