Country Study Start Up Team Leader
Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die Position
Country Study Start\-up Team Leader (cSTL)
Roche Nederland B.V., Woerden
The Opportunity
At Roche, we advance science so that we all have more time with the people we love. In our Global Clinical Operations (PDG) team, we are looking for a Country Study Start\-up Team Leader (cSTL) to take on a dual\-impact role that is vital to our mission.You will be the driving force behind clinical trial submissions while simultaneously serving as a People Leader (for \+\- 30% of your time), guiding a dedicated team to success in our country delivery operations.
In this pivotal role, you will balance strategic oversight of study start\-up with hands\-on leadership in regulatory submissions and people management. Your work ensures that we deliver innovative medicines to patients faster and more efficiently by streamlining the bridge between clinical design and site activation.
In this role, you will:
- Lead the country strategy for study start\-up, driving efficiency and innovation to ensure timely site activation.
- Drive clinical trial submissions and regulatory coordination, managing complex submission packages and responding to Health Authority queries.
- Serve as a People Leader for approximately 30% of your time, providing coaching, support, and professional development to your direct reports.
- Architect and oversee the management of Informed Consent Forms (ICF) and clinical site documentation to ensure global compliance.
- Champion process innovation by identifying opportunities for automation to improve trial initiation timelines.
- Collaborate with global stakeholders, including CROs and Health Authorities, to harmonise systems and influence the local start\-up environment.
- Manage clinical site budgets and contracts, ensuring financial and legal alignment through expert negotiation.
You are a proactive, visionary leader who combines deep technical expertise in clinical submissions with a genuine passion for developing others. You thrive in complex, matrixed environments and possess the analytical prowess to turn data into strategic improvements.
To be successful in this role, you bring:
- Extensive industry expertise: Proven experience in clinical trial start\-up and regulatory submissions, with deep knowledge of ICH\-GCP and EU CTR.
- Transformation leadership: A track record in coaching, mentoring, and leading high\-performing teams to deliver significant business impact.
- Advanced scientific background: A University degree (MD, PhD, MS, or BS) in life sciences; a postgraduate degree is highly desirable.
- Technical proficiency: Experience navigating complex clinical systems such as Veeva Vault, CTIS, and RIM.
- Exceptional communication: The ability to influence and partner with stakeholders, from local operational teams to global executive leadership.
- Language skills: Mandatory fluency in English and fluency in Dutch is strongly preferred
For over 125 years, Roche has been working towards a healthier future with one clear goal: "Doing now what patients need next". We believe that the greatest medical challenges can only be solved through intensive collaboration with healthcare professionals and patients.
Our impact goes beyond healthcare; we also take full responsibility for our planet. For instance, since 2025, all our locations have run on 100% sustainable electricity—a major milestone in our ambition to be fully climate neutral (net zero) by 2045\. At Roche, you are not just working on the healthcare of tomorrow, but also on a healthy, sustainable world.
What you get from us:
- A workplace where fun and social impact come together.
- An organisation where your expertise is valued, and you can make autonomous decisions within your team.
- The chance to work with products that are fundamentally transforming oncological care.
- Abundant opportunities for personal and professional growth; we invest in your unique path.
- Diversity and inclusion are at our heart; we invite you to be your authentic self.
- Excellent benefits including a half 13th month, performance\-based bonus, lease car, 30\.5 days of holiday, and participation in our stock program.
Are you excited about this role and do you recognize yourself in this profile? Feel fry to apply via the "apply now button". If you have any questions, please contact our Talent Acquisition Partner, Matthijs van Heusden, at \+31 6 41607509 or matthijs.van\_heusden@roche.com.
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100\.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik\-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
Deze vacature komt van indeed. Originele vacature bekijken ↗