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.

　　Throughout our history, Edwards has helped transform the way physicians monitor and take preventative measures for cardio patients. Our Critical Care business unit specializes in advanced hemodynamic monitoring solutions, including artificial intelligence algorithms to provide predictive readings to clinicians, helping them get patients home to their families faster. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

　　As the Clinical Contracts Manager for our Critical Care team, you will be responsible 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.

　　The position will be on-site at our Irvine headquarter 5 days/week and a hybrid working schedule can be discussed after the training period is completed.

　　How you will make an impact:

　　Draft, negotiate, and execute the full contract lifecycle for a variety of site and vendor contracts (HCP and non-HCP), including securing appropriate approvals (i.e., Compliance, Legal, Annual Needs Assessments (ANA), and RFPs) where applicable while collaborating with internal stakeholders and external customers utilizing appropriate Edwards' systems (e.g., Electronic Contracts Lifecycle Management System (ECLM))Identify and lead continuous and/or process improvement initiatives across a variety of cross-functional teams within own business unit (BU) or cross-BU teams; may also provide guidance and support to lower-level staff in initiatives they are leading; may provide input on legal-owned contract templatesOversee ongoing vendor lifecycle management, including new supplier onboarding, supplier qualification, COUPA activation/de-activation, annual supplier review/scorecards, and post-project review; Collaborate with clinical stakeholders to identify and qualify new suppliers utilizing appropriate Edwards' systems (e.g., SmartSolve)May assess needs/impacts for contract and budget amendments and provide recommendations to key stakeholders while ensuring compliance with EW policies and mitigating risks to the company; may create contract amendment or form letter templatesMay train and mentor lower level staff on clinical contracting matters, EW policies, and EW systems; assist in developing, finalizing, and updating training and guidance documentsAssist leadership with a variety of analytics or metrics related to executed contracts and budgets or other ad-hoc requests; including establishing reports on various EW systems, running ongoing reports, and providing analysis and metrics on key dataOther incidental duties

　　What you will need (Required):

　　Bachelor's Degree in related field PLUS 8 years 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 Juris Doctor PLUS 6 years of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes

　　What else we look for (Preferred):

　　Experience in healthcare related (clinical, HCP) contracts

　　Additional skills:

　　Proven expertise in Microsoft Office Suite and related contract systemsExcellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectivesExcellent problem-solving and critical thinking skillsExtensive knowledge and understanding of Edwards policies, procedures, and guidelines relevant to contract negotiation and administrationExtensive understanding of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)Extensive understanding of regulatory requirements (e.g., CFR, GCP) and documentsExtensive knowledge of clinical research and operations acumenAbility to manage confidential information with discretionStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentMust be able to work in a team environment, including serving as consultant to managementAbility to interact with senior internal and external personnel on significant matters often requiring coordination between organizationsAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

　　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 $92,000 to $131,000(highly experienced).

　　The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

　　Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

　　COVID Vaccination Requirement

　　Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.