General Summary
As the Clinical Budget Analyst, you will provide essential support to the Clinical Research Department for Penumbra clinical trials and act as a key liaison between the Clinical Research and Legal Departments within Penumbra.
Specific Duties and Responsibilities
• Drive the process of clinical study budget negotiations with the clinical study sites (e.g., hospitals) for multiple clinical studies. *
• Prepare and negotiate site clinical trial budgets and budget amendments. *
• Act as a key liaison between the Clinical Research and Legal Departments. Submit contract requests for clinical studies and investigator-sponsored studies and follow through with internal and external stakeholders to completion. *
• Provide periodic updates to management regarding site start-up progress related to their strategic impact. Communicate potential or actual delays and propose actions to ensure that project timelines are met. *
• Communicates regular updates to clinical project manager and other study staff.
• Proactively identifies potential issues that may arise with budget and contract negotiations
• Partner closely with 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 or related field with 5+ years of experience, or equivalent combination of education and experience
Preferred qualifications:
• Experience in a medical device, pharmaceutical or comparable regulated environment desirable but not essential
• Strong organizational skills and demonstrated competence in word processing and database creation and management are critical skill sets
• 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%
• 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: $93,000 - $130,000
This is the pay range for a mid-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).
