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Sr Mgr, Clinical Affairs

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 15, 2020

Job Description:

The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide. Provide leadership and clinical expertise in support of new product development and/or marketed products.

ESSENTIAL JOB FUNCTIONS AND KEY RESPONSIBILITIES:

• Manage professionals and oversee the work of multiple projects and/or initiatives and may have financial budget responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department.

• Identify risk, develop and lead in the implementation of broad and more complex projects, initiatives and strategies that may include negotiations with internal and external parties. Develop mitigation strategies, alternative solutions, resolve issues, etc. in collaboration with cross-functional and/or matrix teams

• Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables including but not limited to:

• Oversee the relationship management of physicians/investigators, other medical professionals, Research Organizations (CRO's), hospitals, research institutions and/or vendors

• Ensure compliance to applicable regulatory requirements including safety reporting and device-related complications through appropriate oversight

• Oversee clinical studies/registries from initiation to completion, while ensuring study compliance and data completeness_

• Serve as a point of escalation for complex project issues (e.g., sponsor site interaction for IRBs, contract, and training)

• Oversee the Clinical Affairs Trial Management Team during clinical trial cases with physicians, hospital staff and coordinators

MINIMUM REQUIREMENTS:

• Bachelor's or advanced degree in a scientific or related discipline (exceptions only for exceptional candidates or those with professional health certification or designation and commensurate experience).

• Minimum of 12 years consistent and progressive professional experience

ADDITIONAL SKILLS AND GENERAL EXPECTATIONS:

• Demonstrated track record in building teams and people management Required

• Experience working in a regulated industry Preferred

• Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease, and congestive heart failure areas strongly Preferred

• Proven successful project management leadership skills with the ability to meet deadlines on multiple projects

• Proficient in Microsoft Office Suite and related tools and systems (e.g., CTMS)

• Excellent facilitation and presentation skills

• 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 the ability to drive achievement of objectives

• Ability to establish relationships and manage communications with key clinical customers (e.g., physicians, nurses, administrators)

• Ability to work positively through confrontation and/or conflicting ideas

• Expert understanding of clinical regulations/guidelines and procedures (e.g., ICH/GCP E6, ISO14155, CFR 820, Canadian Medical Device Regulation (CMDR), EU MDD/MDR) while identifying applications of functional knowledge and existing methodologies to complex problems

• Excellent financial and business acumen

• Demonstrated ability to manage one or more teams 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

• Ability to develop and integrate metrics into the projects and operations that demonstrate the value of clinical affairs to the business

• Strict attention to detail

• Fully comply with all US and Global regulations, and SOPs in the execution of all job duties

• 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 continuously changing work environment

• Frequently interacts with internal and external management and senior-level stakeholders concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications

• Lead briefings and technical meetings for internal and external representatives

• Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship

• Dedicated to quality client service and pro-active and responsive to client needs.

• Develop peer, cross- functional and cross business relationships to maximize best practice sharing and team effectiveness.

• Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions

• Develop relationships and leverage them to influence change

• Support and solicit input from team members at all levels

• Adhere to all EHS rules and requirements 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

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. SDL2017

Keywords: Edwards Lifesciences, Irvine , Sr Mgr, Clinical Affairs, Other , Irvine, California

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