Mgr Clinical Field Operations EMEA - Abiomed in Aachen bei Johnson & Johnson

Johnson & Johnson

Patients First | Innovation | Winning Culture | Heart Recovery

Job Title: Manager Clinical Field Operations EMEA

Department: Clinical Programs
FLSA Status: Exempt
Location : Germany, homebased

Who are we?

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly-based healthcare company in the world. We’re producing life-changing breakthroughs every day and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are crafting digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world.

Johnson & Johnson – Abiomed

Abiomed is part of Johnson & Johnson MedTech and 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.

Our products have continued to expand in surgical suites across the globe. With our continued success and launch of our new surgical Impella 5.5 platform, we are looking to expand our European Commercial team to develop our surgical business and to ensure best clinical outcomes. Our goal is to establish Heart Recovery as new standard of Care which requires a Heart Team approach.

We are seeking a passionate and experienced Manager Clinical Field Operations to cover the EMEA region .

Purpose of the Role:

The Manager Clinical Field Operations EMEA is responsible for the oversight, growth, and development of our inhouse and remote Lead Clinical Research Associates/ Clinical Research Associates and Clinical Trial Associates. The Manager Clinical Field Operations EMEA is expected to manage site and vendor (e.g. Clinical Research Organization) related matters in collaboration with Clinical Program Managers, and with supervision from the Assoc. Dir, Clinical Affairs and Programs, EMEA & APAC. This person will train, manage, and develop CRAs and CTCs to ensure clinical trials are conducted in a controlled, compliant way, such that safety and privacy of the subjects is ensured with the highest level of data quality and integrity.

What to Expect:

Responsible for hiring, training and retaining a diverse group of in-house and remote CRAs/CTCs, ensuring adherence to pertinent regulations through participation in site visits, regular review of EDC system metrics, Trial Master File review, monitoring reports, communications with Clinical Program Managers, study site personnel, and others as needed
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, bi-annual CRA assessment visits, proactively identifying and addressing any areas of concern, providing development opportunities to team members and as needed, escalating performance and/or personnel issues
Development and maintenance of CRA metrics utilizing Clinical Trial Management System (CTMS)
Collaborate with Clinical Program Managers to identify needs for additional training and to create/refine processes that impact CRA conduct, ensuring consistency in processes across all programs and strict adherence to SOPs, regulations and guidelines
Work closely with Clinical Program Managers to ensure that all studies are appropriately resourced from a monitoring and study support standpoint. This includes tracking resource utilization
Maintains an understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education
Responsible for developing and implementing training programs to train and mentor new clinical research staff as well as providing ongoing education and mentorship to experienced staff
Support CRAs/CTCs through study start up process, ensuring collection of appropriate documentation and timely review of documentation including but not limited to budgets, clinical research agreements and informed consents
Develop a familiarity with the protocols, study timelines, inclusion and exclusion criteria,