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Sr Mgr, Clinical Affairs, Strategic Alliances- AT (Remote

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: February 23, 2021

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Sr Mgr, Clinical Affairs, Strategic Alliances- AT (Remote) USA - California - Irvine An exciting opportunity with the Alliance Management team currently involved in transformational products. You will be responsible for assessing the clinical progress and compliance of external companies where we have strategically invested. You'll be exposed early on to companies that may form the foundation for future Edwards business units or help strategically build our existing BU's! Comprehensive relocation package available or the position can be based remotely. Key Responsibilities: Provide clinical operations expertise in support of new product development and/or marketed products of strategic alliances Monitor complex activities with large scale or significant business impact with the accountability for the successful assessment of all deliverables including but not limited to:

  • Leading clinical diligence efforts, when applicable, for Edwards, participating in protocol development and endpoint definitions with alliance
  • Ensuring compliance to applicable regulatory requirements including assessment of safety reporting and device-related complications through appropriate oversight
  • Assessing alliance SOP's for clinical trial execution
  • Overseeing clinical strategies from initiation to completion, while assessing study compliance and data completeness
  • Independently assessing CRO (if used) capabilities and adherence to trial protocol
  • Independently assessing statistical rationale and biometrics for trial
  • Independently assessing auditing (especially BIMO when applicable) strategies and results
  • Troubleshooting data deficiencies, presentation, and analyses that might be discovered in ongoing trials
  • Reviewing/assessing any clinical sections or modules developed/written by alliance partner
  • Bachelor's Degree is required
  • Relevant clinical trial experience in the medical device, pharmaceutical, or within a CRO organization required. Preferred Qualifications
    • Previous experience with heart valve disease, coronary artery disease, peripheral vascular disease, or heart failure is a plus
    • Proven successful project management leadership skills with ability to meet deadlines on multiple projects
    • Excellent problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision making
    • Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with abilty to drive achievement of objectives
    • Ability to establish relationships and manage communications with key clinical customers (e.g., alliance clinical and regulatory teams)
    • Understanding of clinical regulations/guidelines and procedures (e.g., ICH/GCP E6, ISO14155, CFR 820, Canadian Medical Device Regulation (CMDR), EU MDD/MDR).
    • Ability to develop and integrate metrics into the projects that clearly demonstrate the value of the alliance's clinical program to Edwards' future growth
    • Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment
    • Lead clinical briefings for internal and external stakeholders
    • Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
    • Develop relationships and leverage them to influence change
    • Works independently without close supervision
    • Compares, evaluates, and suggests possible courses of action when necessary
    • Applies his or her knowledge in determining which procedures to follow and more importantly, whether they are being followed
    • Up to 20% Travel E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Posted 2 Days Ago Full time Req-6271 About Us Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.-- For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Keywords: Edwards Lifesciences Gruppe, Irvine , Sr Mgr, Clinical Affairs, Strategic Alliances- AT (Remote, Healthcare , Irvine, California

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