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Field Clinical Operations Manager (w/m/d) EMEA - 2406210126W

Description

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/.

Abiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson MedTech.

Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.

Abiomed Europe GmbH, Johnson & Johnson MedTech is recruiting for a Field Clinical Operations Manager (w/m/d) EMEA , located in Europe, remotely with regular monthly trips to our Headquarters.

Key Responsibilities:

• Hire, train, and retain a diverse and hard-working team of in-house and remote Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs).

• Ensure compliance with pertinent regulations by participating in site visits, reviewing EDC system metrics, monitoring reports, and maintaining regular communication with Clinical Program Managers and study site personnel.

• Develop direct reports through goal setting, performance reviews, mentoring, and coaching, ensuring each team member has opportunities for growth and development.

• Apply CRA metrics using the Clinical Trial Management System (CTMS) and ensure strict adherence to Standard Operating Procedures (SOPs), regulations, and guidelines.

• Collaborate with Clinical Program Managers to identify training needs and create/refine processes that impact CRA conduct to ensure consistency and compliance.

• Resource studies appropriately from a monitoring and study support standpoint, including tracking resource utilization to optimize efficiency.

• Stay updated with clinical regulations and industry standard methodologies, actively engaging in professional associations and continuing education opportunities.

• Develop and implement comprehensive training programs for new and experienced clinical research staff to ensure ongoing education and mentorship.

• Support CRAs and CTCs through the study start-up process, including timely review and collection of essential documentation such as budgets, clinical research agreements, and informed consents.

• Conduct regular Trial Master File (TMF) site audits to ensure inspection readiness and support audit activities.

• Work with Clinical Program Managers to develop, review, and implement Corrective and Preventive Actions (CAPAs).

• Foster a collaborative environment through team-building activities and effective leadership.

Qualifications

Qualifications:

Education:

• A bachelors degree in biological sciences or a related medical/scientific field, or equivalent experience, is required.

• Advanced degree or equivalent experience in a related field is preferred.

Experience and Skills:

Required:

• Minimum of 8 years of direct clinical research experience, with at least 3 years managing CRAs.

• Previous experience as a Lead Clinical Research Associate.

• Expertise with Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.

• High attention to detail and accuracy, with excellent prioritization and organizational skills.

• Proven cross-functional team leadership and participation skills.

• Ability to write and edit technical documents, including protocols, protocol amendments, and informed consents.

• Professional working proficiency in English; proficiency in German or other languages is a plus.

Preferred:

• Experience managing the operation of clinical studies involving Class III cardiovascular devices.

• Proficiency with Microsoft Office Suite and Microsoft Project.

Other:

• Travel up to 40% of the time position is field-based with regular monthly trips to Headquarters.

• Valid drivers license, if applicable.

Johnson & Johnson promotes diversity and inclusivity in employment, regardless of race, religion, gender, age, or disability status.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.

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

Other Locations Europe/Middle East/Africa-France-Haute-de-Seine-Issy Les Moulineaux

Organization Abiomed Europe GmbH Legal Entity

Travel Yes, 25 % of the Time

Job Function Clinical Affairs Management

Req ID: 2406210126W