Senior Clinical Budget Analyst

The Senior Clinical Budget Analyst will provide key support to the Clinical Research Department for Penumbra clinical trials and act as a core liaison between the Clinical Research and Legal Departments within Penumbra.

Requirements

• Lead the process of clinical study budget negotiations with the clinical study sites (e.g., hospitals) for multiple clinical studies.
• Develop, review, and negotiate budgets and amendments for clinical trial sites.
• Serve as a primary point of contact between the Clinical Research and Legal teams by submitting contract requests for clinical and investigator-sponsored studies and coordinating with all parties until finalization.
• Provide management with regular updates on site start-up progress and strategic implications.
• Identify and communicate any potential or actual delays, recommending solutions to keep projects on schedule.
• Maintain ongoing communication with clinical project managers and study teams to provide timely status updates
• Proactively identifies potential issues that may arise with budget and contract negotiations and proposes potential solutions or options*
• Provide training and support for complex budget topics to junior team members
• Identify and participate in ongoing process improvement initiatives when appropriate (i.e., new templates/processes, etc.)
• Enter dates and comments for budget and contract in Clinical Trial Management System (CTMS) in a timely manner
• Partner closely with the Legal team to manage timelines and expectations for new and changing clinical studies on a regular basis.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understands relevant security, privacy, and compliance principles and adheres to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

Benefits

• Medical
• Dental
• Vision
• Life
• AD&D
• Short and long-term disability insurance
• 401(k) with employer match
• Paid parental leave
• Eleven paid company holidays per year
• Fifteen days of accrued vacation per year
• Paid sick time in compliance with applicable law(s)

Originally posted on Himalayas