Clinical Study Start Up Lead

Roche Holding AG; Auckland; On-site; NZD 140,000 - 200,000; Full time

Job summary

Roche Holding AG in Auckland, New Zealand is seeking an experienced Study Start Up Lead (SSUL) to drive country start-up strategy, regulatory submissions, and cross-functional collaboration within the PDG Global Clinical Operations team.

You will bridge local operations with global strategies, oversee ICF management, contracts, and budgeting, and lead process improvements across start-up activities while ensuring compliance and timely trial initiation.

Qualifications

• Requires degree in Life Sciences or equivalent with minimum 4 years of study start up experience.
• Postgraduate or Master’s degree highly desirable.

Responsibilities

• Develop and implement country-level start-up strategies.
• Oversee regulatory and health authority submissions and amendments.
• Manage Informed Consent Form (ICF) preparation and maintenance.
• Oversee site budgets, FMV-based contracts, and compliance.
• Drive process automation and continuous improvement in start-up operations.
• Collaborate with regional/global teams and external authorities.
• Engage affiliates in strategic planning and cross-functional initiatives in New Zealand.

Skills

Clinical operations

Regulatory knowledge

Vendor management

Cross-functional collaboration

English fluency

Education

Life Sciences degree

Postgraduate/Master's preferred

Tools

Veeva Vault

CTIS

RIM

Job description

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.

Die 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 impactsto our employees, customers and the community. We welcome applications from all people and encourageyou 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.