Global Clinical 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

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.