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 Power Point

* 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.

What We Offer

* A collaborative teamwork environment where learning is constant, and performance is rewarded.

* The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.

* A generous benefits package for eligible employees that includes 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).

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and…