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Associate Director, EU Clinical Operations
Location:
Aachen
Description:
Associate Director, EU Clinical Operations Reporting to the Senior Director of Global Clinical Programs, the Associate Director Clinical Programs will manage and support Abiomed-sponsored partnerships at key clinical trial sites throughout Europe. The Associate Director Clinical Programs is responsible for the oversight, growth and development of our in-house and remote Clinical Program Managers, Clinical Project Managers, Clinical Research Associates and Clinical Trial Coordinators and will be responsible for the development and execution of the company's European clinical programs. This person will manage and develop Clinical Program and Clinical Operation personnel to ensure clinical trials are conducted in a controlled, compliant way, such that safety and privacy of subjects is ensured with the highest level of data quality and integrity. The employee will use her/his expertise and clinical trials experience to craft to ensure Abiomed trials are completed on time and in budget in the EU region. Principle Duties and Responsibilities : • Responsible for hiring, develop and retaining a diverse group of EMEA in-house and remote Clinical Program Managers, Clinical Project Managers, Clinical Research Associates, Clinical Trial Coordinators and Clinical Site Contract and Budget Specialists • Accountable for the development of direct reports through performance reviews, instruction, mentoring and coaching. This includes setting goals, conducting periodic and year end performance reviews, proactively identifying, and addressing any areas of concern, providing development opportunities to team members, and as needed, escalating performance and/or personnel issues • Hands on leadership to manage integration of all project team activities including clinical program management metrics, leveraging internal and development partner resources, expertise, and knowledge, along with optimizing CRO resources (when necessary), expertise and knowledge • From protocol design to final clinical study report, leads on-time and in-budget execution of Abiomed sponsored studies in EMEA • Provides strategic input from EMEA on protocol design for specified trials • Effectively communicate and interact with Investigators and other Key Opinion Leaders; Establish and maintain a professional and credible image with key investigators/physicians, consultants, vendors • Interface with Finance, Program Managers, Accounting, Quality, Regulatory, EMEA Medical Affairs and Medical Office (US), which may include leading sub teams and/or acting as a liaison between groups. • Maintains an understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education • Supports Clinical Program Managers and Quality Assurance to ensure that all CAPAs are adequately developed, reviewed, and implemented, • Prepare Clinical Program study budgets and timelines for Worldwide Profit Planning (WWPP) projections for senior management for current and proposed studies. This will include the planning and development of budgets and strategies for randomized controlled trials, post-market studies, etc. • Interface with the Global Clinical Programs peers to ensure excellence in enrollment, compliance, safety, and monitoring of Abiomed sponsored clinical trials • Interface with the EMEA Regulatory Affairs team to ensure a robust and data-driven submission strategy to the competent authorities and notified bodies • Cross-functional collaboration with EMEA commercial teams • Travel to and communicate as a liaison between Abiomed and clinical trial sites• Advanced Degree (M.Sc.) in a scientific and/or business/finance discipline is required. • 6 years of clinical research experience gained with a CRO or Medical Device Company working on later stage, multinational clinical studies involving Germany, UK, France, Netherlands and ltaly. Experience in Class III cardiovascular devices and/or difficult to recruit patient populations (i.e. urgent, emergency room consenting) preferred. Demonstrated success in trial design and execution with diverse research teams • Strong US and EU regulatory knowledge including experience with Ethics Committee and Competent Authority submissions in Germany, UK, Netherlands, ltaly and France, including Good Clinical Practices (GCPs) • Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning, and problem-solving ability. • Excellent communication skills; ability to effectively engage practicing clinicians, scientists, key opinion leaders, industry executives, and regulatory bodies • Excellent analytical skills required; formal training in epidemiology and/or statistics is preferred • Organizational experience leading teams in both a direct reporting and matrix environment • Strong interpersonal, leadership, motivational, and team-building skills and the ability to work in a multicultural, global environment • Ability to make critical strategic business decisions and manage competing stakeholder expectations • Ability to travel frequently, both domestically and internationally • Proficient in computer software and technology required to manage and publish clinical trials For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.
Company:
Johnson And Johnson
Posted:
June 20 on Equest
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