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.
*Indicates an essential function of the role
 
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.

Annual Base Salary Range: $125,000 - $160,000   
This is the pay range for a high-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.