Senior Clinical Budget Analyst

Penumbra • Alameda, CA

2d • Onsite

About The Position

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. This role involves leading budget negotiations, developing and reviewing budgets and amendments, and serving as a primary point of contact between departments to ensure timely finalization of contracts. The analyst will also provide management with updates on site start-up progress, identify and communicate potential delays, and recommend solutions to keep projects on schedule. Ongoing communication with clinical project managers and study teams is essential, as is proactive identification and resolution of issues related to budget and contract negotiations. The position also includes training junior team members, participating in process improvement initiatives, and maintaining accurate records in the Clinical Trial Management System (CTMS). Adherence to the Company’s Quality Management System (QMS) and relevant regulations is mandatory.

Requirements

• 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.
• 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

Nice To Haves

• Clinical research experience in a medical device, pharmaceutical or comparable regulated environment desirable but not essential

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 identify potential issues that may arise with budget and contract negotiations and propose 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.
• Understand relevant security, privacy, and compliance principles and adhere 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, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior