Clinical Budget Analyst

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 …