Full Job Description
As the Clinical Contracts and Budgets Analyst, you will draft and negotiate Non-Disclosure Agreements, Master Clinical Trial Agreements, Scopes of Work, Trial Budgets, and Trial Purchase Agreements for clinical trials, ensuring all terms and conditions comply with applicable regulations and guidelines.
This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine corporate location and have the ability to commute on required onsite days.
How you'll make an impact:
• Initiating, drafting, redlining, and negotiating moderately complex clinical related contracts (Non-Disclosure Agreements, Master Clinical Trial Agreements, Scope of Work, Trial Budgets, Trial Purchase Agreements) based on substantial knowledge policy and regulations governing Clinical Trials and Edwards Policy.
• Identifying risks (e.g. site incentives, legal issues, conflict of interest) and actively engaging with management to provide recommendations for mitigation. Providing clinical input on functional contract terms.
• Analyzing need for contract and budget amendments or renewals and making recommendations, and/or negotiating changes to terms and conditions.
• Identifying risk associated with project timelines set by project teams, impacting team's deliverables and timelines, and key stakeholders' workload (e.g., Legal Compliance, legal contracts, legal privacy, and risk management) based on revised timelines.
• Submitting proposed final draft and supporting documentation through ECLM or CLM system for contract approval and securing appropriate signatures within specified signing authority.
• Identify opportunities for process improvement in collaboration with cross-functional teams; present and implement process improvement plans to management and/or key stakeholders.
What you'll need (Required):
• Bachelor's degree in related field with 3 years of previous related work experience in contract negotiation/administration and financial tracking/analysis against contracts, or equivalent work experience based on Edward's criteria.
• Experience in healthcare-related contracts or equivalent work experience based on Edward's criteria.
What else we look for (Preferred):
• Contract or paralegal certification or equivalent work experience based on Edward's criteria.
• Strong experience with drafting and routing contracts in a Contract Life Cycle Management System (CLM).
• Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, Excel, and SharePoint.
• Extensive knowledge and understanding of Edwards policies, procedures, and guidelines relevant to contract negotiation and administration.
• Extensive understanding of the NDA, MCTA, SOW, and TPA templates and drafting to negotiate and redline contractual language.
• Understanding of medical device trials, GCP, and compliance requirements.
• Ability to collaborate with the Study Team and Clinical Project Manager to strategize on site prioritization and enable fast site activation.
• Advanced written and verbal communication skills and interpersonal relationship skills.
• Proven problem-solving, organizational, analytical, and critical-thinking skills.
• Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects.
• Ability to build internal/external working relationships.
• Strict attention to detail.
• Ability to manage competing priorities in a fast-paced environment.
• Ability to interact professionally with all organizational levels.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $68,000 to $96,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
