Manager, Clinical Contracts and Budgets job opportunity at Edwards Lifesciences Corporation.

Home Jobs In United States Of America Tag: Clinical Contracts and Budgets Manager, Clinical Contracts and Budgets position at Edwards Lifesciences Corporation


DateMore Than 30 Days Ago bot
Edwards Lifesciences Corporation Manager, Clinical Contracts and Budgets
Experience: 8-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Clinical Contracts and Budgets

Copy Link Report
degreeMaster's (M.A.)
loacation USA - California – Irvine, United States Of America
loacation USA - Californ..........United States Of America

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under‑diagnosed and under‑treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life‑changing solution for patients by offering heart valve replacement without the need for open‑heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As the Manager, Clinical Contracts and Budgets, you will be responsible for the full clinical contract and budget negotiation lifecycle, partnering closely with clinical study teams, hospitals, vendors, consultants, and cross‑functional groups such as Legal, Finance, and Compliance to develop, negotiate, and lead the execution of a wide range of clinical contracts while applying both legal and clinical expertise. 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: ​ Manage and oversee the work of assigned team of Analysts providing mentorship and guidance to support their growth and ensure operational excellence. Help implement and foster a robust talent development plan in alignment with functional growth strategies of the department. Train and coach lower-level employees on basic clinical, budget, and contracts matters. Monitor staff’s progress (e.g., follow-up and output) to ensure that direct reports are following up with their assigned sites in the timelines identified by leadership. Draft, negotiate, and execute the full clinical contract lifecycle for a variety of progressively complex contract types at high quality (e.g., Master Clinical Trial Agreements, Statements of Work (including budgets), Non-Disclosure Agreements, and/or Purchase Agreements, utilizing appropriate Edwards templates and systems). Assess needs for basic contract and budget amendments and provide guidance to stakeholders, make recommendations, and/or negotiate changes to terms and conditions while mitigating risks to the company. Identify and mitigate risks with low, moderate, and high exposure to the company and create and implement corrective action plans to prevent repeat of risks. Escalate contract delays, external and internal issues and hurdles in a timely manner to leadership and key stakeholders and suggest solutions. Develop budgets (e.g. study and/or vendor) of moderate complexity based upon fair market value assessments with in-depth understanding of clinical project scope in collaboration with clinical study leaders. Provide input on basic legal-owned contract templates. Work cross-functionally in collaboration with Clinical Study Teams, Hospitals, Vendors, Consultants, Legal, Finance, and Compliance to develop, negotiate, and execute a wide range of clinical agreements. Ensure contracts are strategically aligned with regulatory requirements, budgetary goals, and study timelines to accelerate the delivery of innovative therapies to patients. Other incidental duties assigned by Leadership. What you'll need (Required): Bachelor’s degree or equivalent in related field with 8 years of experience of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes Or master's degree or equivalent with 6 years of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes. Ability to travel up to 5% domestically What else we look for (Preferred):   Juris Doctor or equivalent with previous related experience with Clinical Study Agreements, Informed Consents, Non-Disclosure Agreements. Experience in healthcare related contracts. Contract or paralegal certification Demonstrated supervisory experience, including the ability to lead, mentor, and oversee the work of direct reports while fostering a high‑performing, collaborative team environment. Proven expertise in Microsoft Office Suite and working proficiency with contract lifecycle management (CLM) systems. Excellent written and verbal communication skills, including negotiating and relationship management, with the  ability to drive alignment and achieve objectives. Strong problem-solving and critical thinking abilities. Extensive understanding of clinical study protocols, assessments, and imaging. In-depth understanding of Master Clinical Trial Agreements, including terms and conditions. Deep knowledge of medical terminology, healthcare compliance, and privacy regulations (e.g., HIPAA, Sunshine Act). In-depth understanding of Master Clinical Trial Agreements, including terms and conditions. Skilled in drafting legal language and proficient in redlining. Experienced in telephone-based negotiations for contracts, terms, and budgets. Ability to develop and integrate metrics that demonstrate the value of clinical contracts  to the business Provide support and guidance to team members during contract negotiations to identify optimal solutions. Responsible for employee management activities such as hiring, performance development, and partnering with HR on employee relations. Maintain strict attention to detail and stay current on healthcare regulations and industry trends, including Fair Market Value assessments and CPT codes. Monitor key contract terms, expiration dates, and deliverables to ensure timely renewals and amendments. Strong knowledge of clinical research operations and cross-functional collaboration. Capable of managing competing priorities in a fast-paced environment and adapting to shifting business needs. Ability to interact professionally across all organizational levels and influence cross-functional leadership to gain alignment. Ability to manage and support a team, including training, coaching, and providing guidance tor staff on clinical, budget, and contract matters. Comfortable working in a team environment and making recommendation to reach an optimal solution to a problem or negotiation. Able to coordinate with senior internal and external stakeholders on significant matters and provide subject matter expertise and guidance to others. 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, the base pay range for this position is $105,000 to $148,000 (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.  E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Other Ai Matches

remote-jobserver Remote
Territory Manager, Surgical, New Delhi Applicants are expected to have a solid experience in handling Surgical, New Delhi related tasks
Sales Rep, TMTT, Osaka or Nagoya Applicants are expected to have a solid experience in handling TMTT, Osaka or Nagoya related tasks
Director of Product Marketing Applicants are expected to have a solid experience in handling Job related tasks
Senior Field Clinical Specialist, THV -Turkey Applicants are expected to have a solid experience in handling THV -Turkey related tasks
Field Clinical Specialist, Las Vegas - Transcatheter Heart Valve Applicants are expected to have a solid experience in handling Las Vegas - Transcatheter Heart Valve related tasks
Field Clinical Specialist THV - Piemonte Applicants are expected to have a solid experience in handling Job related tasks
Clinical Graduate Program Applicants are expected to have a solid experience in handling Job related tasks
Regional Field Manager (THV) Southern Italy Applicants are expected to have a solid experience in handling Job related tasks
Associate Valve Treatment Operator Applicants are expected to have a solid experience in handling Job related tasks
Senior Specialist, Professional Education (HCP basic training management) Applicants are expected to have a solid experience in handling Professional Education (HCP basic training management) related tasks
Workplace Experience and Events Manager Applicants are expected to have a solid experience in handling Job related tasks
Associate Specialist, Labeling Applicants are expected to have a solid experience in handling Labeling related tasks
Senior Manufacturing Engineer Applicants are expected to have a solid experience in handling Job related tasks
Senior Specialist, Regulatory Affairs TMTT Applicants are expected to have a solid experience in handling Regulatory Affairs TMTT related tasks
Field Clinical Specialist TMTT (Based in Minas Gerais, Goiânia or Brasilia) Applicants are expected to have a solid experience in handling Goiânia or Brasilia) related tasks
Therapy Development Manager, Los Angeles - Transcatheter Heart Valve Applicants are expected to have a solid experience in handling Los Angeles - Transcatheter Heart Valve related tasks
Principal Compliance Specialist, Product Stewardship Applicants are expected to have a solid experience in handling Product Stewardship related tasks
Manager, Physician Training Applicants are expected to have a solid experience in handling Physician Training related tasks
Senior Manager, IT Cloud Applicants are expected to have a solid experience in handling IT Cloud related tasks
Field Clinical Specialist, Sapien M3 Applicants are expected to have a solid experience in handling Sapien M3 related tasks
remote-jobserver Remote
Senior Clinical Field Specialist, TMTT, Qld Applicants are expected to have a solid experience in handling TMTT, Qld related tasks
Treasury Director, Foreign Risk Management Applicants are expected to have a solid experience in handling Foreign Risk Management related tasks
Technologist, Process Technology Applicants are expected to have a solid experience in handling Process Technology related tasks