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Clinical Project Manager (m/f/d) - 2406193845W

Description

Johnson & Johnson is currently seeking a Clinical Project Manager (m/f/d) to join our Abiomed team located in Germany.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

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.

The Clinical Project Manager is responsible for managing the operational activities of a portfolio of assigned clinical research studies. This includes the planning, development and follow-up of systems and procedures to ensure optimum compliance in accordance with applicable laws and guidelines, including GDPR to ensure operating quality and efficiency.

Primary Duties and Responsibilities:

• Responsible for comprehensive management for clinical research study, for example protocol and database development, site management and monitoring, project planning

• Chair team meetings for assigned studies ensuring goals and deliverables are clearly defined, and issues, decisions, risks, and actions are appropriately tracked

• Responsible for project development & performance tracking and risk management

• Oversee and contribute to development of key study documents including, but not limited to study protocols, protocol amendments, study plans and procedure manuals, project tools, informed consent forms and clinical study reports,

• Accountable to conduct clinical research programs in accordance with approved project plan, compliance to company standard operating procedures and applicable regulations.

• Analyze and develop action plans for sites, vendor, and administrative issues

• Provide Quality Assurance support and management level representation during audits and inspections.

Qualifications

Qualifications:

• BS degree in Science, Engineering, or related medical/scientific field; MS or graduate degree preferred

• Minimum of five years’ experience in clinical research, experience in cardiovascular devices preferred

• Expertise with GCP and regulatory compliance guidelines for clinical trials required

• Solid EU regulatory knowledge including experience with Ethics Committee and Competent Authority submissions in Germany, Switzerland, Italy

• Experience with site and sponsor level Regulatory Authority investigation(s) preferred

• Polished communication and presentation style

• High attention to details and accuracy; Excellent prioritization, organizational skills

• Excellent interpersonal communication skills; Works effectively on cross-functional teams

• 35% travel

Primary Location Europe/Middle East/Africa-Germany-North Rhine Westphalia-Aachen

Organization Abiomed Europe GmbH Legal Entity

Job Function Project/Program Management

Req ID: 2406193845W