Original listing text, shown exactly as published by the company.
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.
