Sr. BA - Clinical operations

Integrated Resources Inc.; Princeton (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking an experienced project management/business analyst for a role in Princeton, NJ. This role involves managing extensive clinical trials, ensuring regulatory compliance, and bridging gaps between business processes and technology. Candidates should possess strong analytical, technical writing, and networking abilities, with a proven track record in the clinical research arena.

Qualifications

• 9-11 years in pharmaceutical company/CRO with business analysis and project management.
• Strong understanding of clinical research, regulatory documentation, and IT systems.
• Proven ability to prepare business cases and road maps.

Responsibilities

• Manage end-to-end clinical trials, ensuring compliance with regulations.
• Draft RFI/RFP and lead industry research to offer solutions.
• Serve as a business process consultant focused on continuous improvement.

Skills

Clinical Research

Project Management

Technical Writing

Analytical Skills

Networking

Job description

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.