Senior Clinical Budget Analyst at Penumbra Inc in Alameda, CA

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. 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.