Jobs › Companies › Roche › Clinical Study Start Up Lead

Über diese Clinical Study Start Up Lead Stelle bei Roche

Roche · Vor Ort · Auckland

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position


A healthier future. It is what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That is what makes us Roche.

 

●       Secure a permanent career path with the global leader in medical innovation.

●       Champion meaningful change to enhance outcomes for our partners and patients.

●       Thrive within a high-performing, agile network that empowers visionary leadership.

 

At Roche, we believe every patient deserves access to healthcare innovations. We are seeking an experienced Study Start Up Lead (SSUL) to join our Pharma Product Development Global Clinical Operations (PDG) team based in Auckland, New Zealand.

 

In this pivotal role within the License to Operate (LTO) Chapter, you will lead the country strategy for study start-up, driving efficient, compliant, and innovative clinical trial initiation. You will bridge local operational execution with global strategies, collaborating closely with internal teams, Ethics Boards, Health Authorities, and CRO partners to bring life-changing therapies to patients faster.

 

Key Responsibilities include;

 

  • Start-Up Strategy & Execution: Develop and implement country-level start-up strategies, proactively mitigating risks and overseeing site activation to meet global milestones.
  • Regulatory & Ethical Coordination: Oversee clinical trial applications, health authority query responses, and study lifecycle amendments in strict adherence to regulatory standards.
  • ICF Management: Strategically oversee Informed Consent Form (ICF) preparation, submission, and maintenance to align with corporate and compliance requirements.
  • Contracts & Budgeting: Oversee site budget strategies based on Fair Market Value (FMV), contract negotiations, clinical site agreements, and financial/legal compliance.
  • Process Innovation: Identify and drive opportunities for process automation, standardization, and continuous improvement across start-up operations.
  • Stakeholder Engagement: Collaborate with regional/global counterparts, external industry networks, and local health authorities/ethics boards.
  • Affiliate Culture: Actively participate in affiliate strategic planning, Big Room Planning, and cross-functional team initiatives in New Zealand.

 

Who you are;

 

  • Education: Degree in Life Sciences or equivalent (Postgraduate or Master’s degree highly desirable) with minimum 4 years of relevant study start up experience.
  • Regulatory Knowledge: Solid understanding of ICH-GCP guidelines, local regulatory frameworks, and clinical trial operational workflows.
  • Vendor Management: Proven experience working with and overseeing vendor and CRO relationships.

Skills & Competencies

  • Proficiency with clinical systems (e.g., Veeva Vault, CTIS, RIM).
  • Outstanding communication, negotiation, and cross-functional collaboration skills.
  • Strong organizational, analytical, and complex problem-solving abilities.
  • Ability to thrive and lead in a matrixed, international team environment.
  • Full fluency in written and spoken English.

 

Working Conditions

  • Position is based in Auckland, New Zealand.
  • Requires flexibility for some national and international travel.
  • Occasional evening and weekend work may be required to support global trial schedules.

 

This role is only open to candidates that have full eligibility to live and work in New Zealand.

 

We do not accept any unsolicited resumes or enquiries from recruitment agencies. Roche has a dedicated in-house Talent Acquisition team.


 

 

What we offer

Roche offers rewarding growth opportunities, a competitive remuneration package and a collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders. 

Roche encourages a high-performance culture where you are empowered and trusted to make decisions. We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients.

Take pride in knowing you can make a difference to millions of patients worldwide in developing diagnostics and treatments for oncology, neuroscience, inflammation, immunology, ophthalmology, rare diseases, respiratory disease and diabetes.

We are committed to providing an inclusive, safe, secure and healthy workplace, and to minimise any such impacts to our employees, customers and the community. We welcome applications from all people and encourage you to advise of any individual circumstances that may require consideration.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.


Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

Bereit, sich bei Roche zu bewerben?
Bei Roche bewerben

Über Roche

We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Alle Jobs bei Roche ansehen →

Ähnliche Jobs

Roche
Principal Technical Sub-Project Manager (Drug Product Filling & Compounding Equipment)
Roche
⚡ Früh bewerben Hillsboro Vor Ort $109,900–$204,100
● Neu 👁 Gesehen ✓ Beworben vor 1 Std.
Roche
Scientist Pharmaceutical and Processing Development
Roche
⚡ Früh bewerben Basel Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 1 Std.
Roche
Procurement Enablement - Procurement Capability Lead - Supplier Relationship Management (SRM)
Roche
⚡ Früh bewerben Welwyn Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 1 Std.
Roche
Project (R&D Product Life Cycle) Manager (12 months)
Roche
⚡ Früh bewerben Welwyn Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 1 Std.
Roche
Digital Innovation Board and Portfolio Lead - Pharma Technical Operations
Roche
⚡ Früh bewerben Madrid Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 1 Std.
Roche
Digital Marketing Operations Associate
Roche
⚡ Früh bewerben Petaling Jaya Hybrid
● Neu 👁 Gesehen ✓ Beworben vor 9 Std.
Roche
Territory Manager (Individual Contributor) - Coimbatore
Roche
⚡ Früh bewerben Chennai Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 9 Std.
Roche
Finance Excellence Partner
Roche
⚡ Früh bewerben Sant Cugat del Vallès Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 9 Std.
Roche
Business Capability Lead - SAP
Roche
⚡ Früh bewerben Mumbai Vor Ort
● Neu 👁 Gesehen ✓ Beworben vor 9 Std.

Registrieren für Vorschläge, die auf die von Ihnen geöffneten Jobs und gespeicherten Suchen zugeschnitten sind.

Mehr Jobs bei Roche

Alle Jobs bei Roche ansehen →

Jetzt bewerben
🤖

Moment — langsam

JobsRadar wurde für echte Menschen gebaut, die eine schwere Zeit bei der Jobsuche haben — nicht für automatisierte Anfragen. Sie klicken viel zu schnell und sind jetzt vorübergehend blockiert.

Kommen Sie später wieder. Wenn Sie wirklich auf Jobsuche sind, stehen wir hinter Ihnen — verhalten Sie sich einfach wie ein Mensch.

Catch your next role the second it’s posted.

Create a free account and we’ll watch the boards for you — the instant a job matches your search, it lands in your inbox or Telegram. No digging, no refreshing.

Create free account

Free forever · takes 30 seconds · already have one?

Verschaffe dir einen Vorsprung bei der Jobsuche.

Tritt unserem Telegram-Kanal bei für das, was dir hilft, die Stelle zu bekommen — Gehaltsbenchmarks, den wöchentlichen Marktpuls und neue Feature-Drops. Kein Spam, nur Signal.

Dem Kanal beitreten — kostenlos