Clinical Program Manager (m/w/d)

Dexcom, Inc.; United Kingdom; Hybrid; GBP 45,000 - 80,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Clinical Program Manager, der strategische Leitung und Richtung für klinische Studien bietet. In dieser spannenden Rolle werden Sie die Planung und Durchführung klinischer Studien leiten, um sicherzustellen, dass die Unternehmensziele erreicht werden. Sie arbeiten eng mit verschiedenen Funktionsgruppen zusammen und bringen Ihre Fähigkeiten in der Kommunikation, Organisation und Problemlösung ein. Das Unternehmen bietet ein dynamisches Umfeld mit Möglichkeiten zur beruflichen Weiterentwicklung und einem hybriden Arbeitsmodell, das Flexibilität und eine inklusive Kultur fördert. Wenn Sie eine Leidenschaft für die Verbesserung der Diabetesversorgung haben, ist dies die perfekte Gelegenheit für Sie.

Benefits

Umfassende Einarbeitung und Schulung

Diverse und inklusive Arbeitsumgebung

Hybrides Arbeitsmodell

Zusätzliche Urlaubstage

Möglichkeit, aus anderen Ländern zu arbeiten

Krankenversicherung

Lebens- und Unfallversicherung

Private Rentenversicherung

Gesundheits- und Wellnessprogramme

Regelmäßige Teambuilding-Events

Qualifications

• 5-8 Jahre Erfahrung in der Leitung klinischer Studien erforderlich.
• Starke Kenntnisse in den Guten Klinischen Praktiken (GCPs).
• Erfahrung in der Planung und Durchführung klinischer Studien in der Medizintechnik.

Responsibilities

• Leitung und strategische Planung klinischer Studien zur Unterstützung der Unternehmensziele.
• Zusammenarbeit mit verschiedenen Funktionsgruppen zur Umsetzung von Studienstrategien.
• Überwachung der operativen Abläufe und Risikomanagement während der Studien.

Skills

Regulatory Knowledge

Communication Skills

Organizational Skills

Problem-Solving Ability

Leadership Qualities

Interpersonal Skills

Education

Bachelor's degree in biological sciences

Master's degree in related field

PhD in relevant discipline

Tools

MS Office Suite

MS Project

Smartsheet

Job description

Über Dexcom

Dexcom, Inc. (NASDAQ: DXCM) wurde 1999 gegründet und entwickelt und vermarktet Systeme zur kontinuierlichen Glukoseüberwachung (CGM) für den ambulanten Einsatz durch Menschen mit Diabetes und durch Gesundheitsdienstleister zur Behandlung von Menschen mit Diabetes. Das Unternehmen ist führend bei der Umgestaltung der Diabetesversorgung und -behandlung, indem es CGM-Technologie bereitstellt, um Patient:innen und medizinisches Fachpersonal bei der besseren Behandlung von Diabetes zu unterstützen. Seit der Gründung des Unternehmens hat sich Dexcom auf bessere Ergebnisse für Patient:innen, Pflegekräfte und Ärzt:innen konzentriert, indem es erstklassige Lösungen liefert und gleichzeitig die Gemeinschaft in die Lage versetzt, Diabetes in den Griff zu bekommen. Dexcom meldete für das Gesamtjahr 2022 einen Umsatz von 2,9 Milliarden US-Dollar, ein Wachstum von 18% gegenüber 2021. Das Unternehmen mit Hauptsitz in San Diego, Kalifornien, und weiteren Niederlassungen in den USA, Europa und im asiatisch-pazifischen Raum beschäftigt weltweit über 9.000 Mitarbeiter.

Meet the Team:

As a Clinical Program Manager you will provide leadership and direction to Clinical Affairs in planning and execution of clinical strategies in a key business area. A successful leader in this role will understand and translate business strategy into planning an execution of clinical studies to support broader objectives.

Excellent communication skills are required to manage and facilitate collaborations within the Clinical Affairs team, with all internal core team functional groups, and with external partner stakeholders. This role requires a strong technical background and experience in both product development and clinical study planning and execution, ideally in a regulated environment such as medical device development.

** You must have the Right to Work in the UK. Sponsorship is not available for this role **

Where You Come In:

1. You will serve as a member of core team(s), providing strategic direction to study teams to meet goals and timelines.
2. You will interface with representatives from key functional groups including Executive Management, Product Development/R&D, Regulatory Affairs, Quality Assurance, and Operations as well as Clinical Research Organizations (CROs) to set operational direction and strategy for clinical study activities.
3. You will work in collaboration with functional leaders to design/implement strategies and track project plans related to study design.
4. You will drive the full spectrum of the clinical execution from the design phase to close-out in collaborating closely with the study team.
5. You will track and manage strategic study operations including KPIs, study timelines, all budgetary and financial information, etc.
6. You will coordinate and prioritize activities amongst trials/establish study milestones to ensure timelines are met.
7. You will recommend and implement innovative ideas to increase efficiency and quality of study management activities.
8. You will identify and mitigate risks to study implementation, enrollment, conduct, compliance, and completion.
9. You will drive selection of Contract Research Organizations (CROs) through competitive bid process and other necessary vendors to support study requirements.
10. You will provide oversight and execution of CRO study deliverables to ensure that objectives are met.

What Makes You Successful:

1. Bachelor's degree in biological sciences or related medical/scientific field with a minimum 5-8 years leading clinical studies.
2. You have a strong regulatory knowledge, including Good Clinical Practices (GCPs).
3. You have experience with protocol and ICF development.
4. You have experience with clinical study planning and execution in the medical device industry.
5. You have exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
6. You have excellent communication (written and verbal) and presentation skills along with leadership qualities.
7. You have strong interpersonal skills and ability to work effectively on cross-functional & global teams.
8. You thrive in an extremely fast-paced environment.
9. Successful experience managing outside CRO groups in Class II/III, preferably diabetes, device studies would be an advantage.
10. Proficient with MS Office Suite (Excel, Word and PowerPoint), MS Project, and Smartsheet would be an advantage.

What You'll Get:

1. A comprehensive onboarding and training on the job.
2. Opportunity to work in a diverse and inclusive environment with colleagues representing 45 different nationalities.
3. Hybrid working model, offering the flexibility to work both remotely and in a modern, well-equipped office space.
4. 5 additional vacation days, with potential for more for parents, students, and other cases with approval.
5. Opportunity to work from other countries for up to 30 days per year.
6. Health Insurance including reduced premiums available for dependents.
7. Life and Accident insurance coverage.
8. 3rd Pillar Private Pension plan.
9. Health and Wellness programs, including access to online coaching and therapy sessions.
10. Fertility, Family forming, Menopause and Men's health support services.
11. Regular team-building events that foster collaboration and connection.
12. Best-in-class training and career development programs.
13. Exclusive discounts on restaurants, spas, clothing, gyms, entertainment, and more.
14. Access to a fitness tracking app with rewards for staying active.
15. Free parking space at the city center office location.

Travel:

1. 10-15%

Experience and Education Requirements:

1. Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.