Clinical Study Start Up Lead

F. Hoffmann-La Roche AG; Auckland; On-site; NZD 120,000 - 160,000; Full time

Job summary

Roche in Auckland, New Zealand, seeks an experienced Study Start Up Lead to drive country strategy for start-up activities, ensuring timely, compliant initiation of clinical trials and collaboration with ethics boards, health authorities, and CRO partners.

The role requires a Life Sciences degree with 4+ years in study start-up, strong regulatory knowledge, and excellence in cross-functional communication. Travel may be required; full eligibility to work in New Zealand is essential.

Qualifications

• Regulatory knowledge: ICH-GCP and local rules.
• Vendor/CRO management experience.

Responsibilities

• Start-Up Strategy & Execution: develop country start-up plans and activate sites on time.
• Regulatory & Ethical Coordination: manage regulatory submissions and ethics approvals.
• ICF Management: oversee ICF prep, submission, and maintenance.
• Contracts & Budgeting: oversee FMV-based budgets and site agreements.
• Process Innovation: drive automation and standardization across start-up ops.
• Stakeholder Engagement: coordinate with regional/global teams, authorities, and CROs.
• Affiliate Culture: contribute to NZ affiliate planning and cross-functional workstreams.

Skills

Veeva Vault

CTIS

RIM

Cross-functional collaboration

Communication skills

English fluency

Education

Life Sciences degree

Master’s degree in Life Sciences

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. 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

• 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.

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.