Clinical Budget & Contract Analyst
Job Summary
Job Description
The Clinical Budget and Contract Analyst provides crucial support to Penumbra's Clinical Research Department for clinical trials. This role acts as a key liaison between Clinical Research and Legal Departments. Responsibilities include negotiating clinical study budgets and contracts with sites, preparing budget amendments, submitting contract requests for clinical studies, providing updates on site start-up progress, identifying potential budget/contract issues, and partnering with the Legal team. The Analyst ensures adherence to the Quality Management System (QMS) and relevant regulations. Strong organizational, communication, and problem-solving skills are essential, along with proficiency in MS Office Suite. The position requires managing a high volume of work and meeting deadlines in a fast-paced environment.
Must have:
- Negotiate clinical trial budgets & contracts
- Liaison between Clinical Research & Legal
- Budget preparation & amendments
- Strong organizational & communication skills
- Adherence to QMS & regulations
Good to have:
- Experience in medical device/pharmaceutical environment
- Creative problem-solving skills
Perks:
- Collaborative teamwork environment
- Generous benefits package (medical, dental, vision, life insurance, 401k, stock purchase plan, paid parental leave)
- Paid holidays and vacation time
6 skills required
Job Details
General Summary
As the Clinical Budget and Contract 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 and contract 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 related experience experience, or equivalent combination of education and experience
Additional 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, an employee stock purchase plan, 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 markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
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, an employee stock purchase plan, 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 markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
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