Manager, Clinical Contracts - Transcatheter Mitral and Tricuspid Therapies

This is an exciting opportunity for you to join a fast-paced, dynamic team boldly designing transcatheter mitral and tricuspid therapies from the ground up. Edwards' Transcatheter Mitral and Tricuspid Therapies team is deeply dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients' lives around the world.   The Manager, Clinical Contracts will manage a clinical contracts team with responsibility  for the full clinical contract lifecycle including partnering closely with clinical study teams, hospitals, vendors, consultants, Legal, Finance and Compliance groups to develop and lead the execution of a variety of clinical contracts while applying legal and clinical expertise. Depending on experience level, we are open to hiring at the Associate Manager or Manager level. This role is located in Irvine, California Essential Job Functions: Manage and oversee the work of assigned team within own function and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department Draft, negotiate, and lead the execution of the full clinical contract lifecycle for a variety of complex contract types (e.g., clinical trial agreements, non-disclosure agreements, and vendor contracts), utilizing appropriate Edwards systems (e.g. ECLM).   Assess needs for contract and budget amendments and provide guidance to key stakeholders, make recommendations, and/or negotiate changes, to terms and conditions while mitigating risks to the company Develop study budgets based upon fair market value assessments with in-depth understanding of clinical project scope in collaboration with clinical study teams.  Develop processes to maintain and track business unit and payment milestones against contract terms utilizing CTMS by working with study team, database developers and data management. Provide clinical team oversight and work direction with regard to clinical systems such as the Clinical Trial Management System (CTMS), electronic Trial Master File, and other operational systems. Approve payment issuance in accordance with contract terms. Develop and lead the implementation of continuous process improvement projects Other duties as assigned by Management #LI-MO1 #MI Required Education/Skills/Experience:  Bachelor's degree in related field required 10 years of related experience (8 years for Associate Manager level) with Clinical Study Agreements, Informed Consents, Consulting and Vendor contracts along with knowledge of supplier qualifications processes Experience inclusive of at least 5+ years dedicated to clinical contract negotiation/administration specific to Clinical Trial Agreements required 4+ years of people management experience  (2+ years for Associate Manager level) with the ability to lead and inspire a clinical contracts team Depending on experience level, we are open to hiring at the Associate Manager or Manager level. Preferred: Contract or paralegal certification preferred Experience obtained in Medical Device, CRO, Biotech, Pharmaceutical industries strongly preferred. Experience in international clinical study contract administration preferred. Additional Talents and General Expectations:  Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations Experience in healthcare related contracts preferred Proven expertise in Microsoft Office Suite and related contract systems Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives    Excellent problem-solving and critical thinking skills Recognized as an expert in own area with specialized depth within the organization Expert knowledge and understanding of Edwards policies, procedures and guidelines relevant to contract negotiation and administration Expert knowledge of medical terminology and healthcare regulations (e.g. HIPAA and Sunshine Act) Expert knowledge of all legal aspects of contracting and the ability to understand contract language and quickly identify/communicate any risks or liabilities Strict attention to detail Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical contracts to the business Ability to manage competing priorities in a fast-paced environment Ability to provide guidance to others on area of expertise 016687
Salary Range: NA
Minimum Qualification
8 - 10 years

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