Senior Clinical Budget Analyst

General Summary

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.

Specific Duties and Responsibilities

• 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.

Position Qualifications

Minimum education and experience:

• Bachelor's degree in life sciences, business, finance, legal, or related field with 8+ years of clinical budget or similar relevant experience, or equivalent combination of education and experience.

Additional qualifications:

• Clinical research experience in a medical device, pharmaceutical or comparable regulated environment desirable but not essential.
• Strong organizational skills.
• Experience in creating and negotiating budgets.
• Familiarity with clinical trial agreements (contracts).
• Ability to process a high volume of work and meet deadlines in a fast-paced environment is essential.
• High degree of accuracy and attention to detail necessary.
• Creative problem-solving skills are highly desirable.
• Outstanding written, oral, and interpersonal communication skills are required.
• Proficiency with MS Word, Excel, and PowerPoint.
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously.

Working Conditions

• General office, laboratory, and cleanroom environments.
• May have business travel from 0% - 5%.
• Potential exposure to blood-borne pathogens.
• Requires some lifting and moving of up to 15 pounds.
• Must be able to move between buildings and floors.
• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be able to move within the office and access file cabinets or supplies, as needed.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.