Study Start Up Lead

F. Hoffmann-La Roche AG; Hong Kong; On-site; HKD 900,000 - 1,300,000; Full time

Job summary

Roche in Hong Kong seeks a Senior Leader to drive country study start-up strategies for clinical trials, coordinating with local teams, global study groups and CROs to ensure timely site activation and regulatory compliance. You will manage submissions, ICF, budgeting, and cross-functional processes, translating global strategies into local execution while ensuring quality and patient safety.

Fluency in English and Cantonese, strong leadership, and deep knowledge of ICH-GCP and regional

Qualifications

• Degree in life sciences or equivalent; postgraduate degree desirable.
• Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration.
• Strong understanding of ICH-GCP, EU CTR, and local regulatory environments.
• Experience managing vendor/CRO relationships.
• Proven leadership or line management experience for project leads.

Responsibilities

• Lead country study start-up strategy and execution with external stakeholders.
• Oversee start-up operations, site activation, and regulatory compliance.
• Ensure alignment with global strategies and timelines across functions.
• Manage amendments throughout the study lifecycle.
• Identify opportunities for process automation and standardisation.
• Collaborate with regional and global teams to harmonise systems and timelines.

Skills

Communication

Organizational skills

Analytical thinking

English fluency

Cantonese

Education

Life sciences degree

Postgraduate degree desirable

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.

Position Purpose, Objectives and Scope of Position

As a member of the PDG Country Study Start‑up Team, your primary focus is to drive and facilitate efficient study start‑up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery, address study start‑up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators, and clinical site staff. Collaboration with local internal and external country teams, global study teams, and CROs is essential to this role.

Key Responsibilities

• Leading the country strategy for study start‑up, driving efficiency, innovation, and collaboration with external stakeholders.
• Overseeing start‑up operations and ensuring timely and efficient site activation and regulatory compliance.
• Ensuring alignment with global strategies and timelines.
• Managing amendments throughout the study lifecycle.
• Identifying and driving opportunities for process automation, standardisation, and innovation.
• Collaborating with regional and global counterparts to harmonise systems and improve timelines.
• Participating in external industry collaborations to influence country start‑up environments.
• Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities).

Study Start‑up Strategy & Execution

• Lead teams in the creation of the study start‑up strategy and execution of the study start‑up process, encompassing strategy development, proactive risk mitigation, regulatory compliance, stakeholder liaison, tracking, knowledge management, and collaborative planning with CRO partners.

Informed Consent Form (ICF) Management

• Architect and strategically oversee ICF management, including preparation, submission, archiving to ensure compliance, alignment with corporate requirements and best practices.

Clinical Trial Submissions & Regulatory Coordination

• Lead the development and oversight for clinical trial submissions, amendments and regulatory coordination, managing packages, responding to queries, ensuring document maintenance, and supporting amendments throughout the trial lifecycle.

Site Documentation & Compliance

• Strategically manage site documentation and compliance, overseeing document collection/validation, coordination of related processes, and local vendor management (excluding CROs) if needed.
• Oversee translation and approval of drug labels and patient‑facing materials, as required.
• Maintain up‑to‑date knowledge of country‑specific regulations, including those for medicinal products, medical devices, and IVDRs.

Budgeting & Contract Management

• Provide comprehensive strategic planning, oversight and implementation for all aspects of budgeting and contract management, including developing Fair Market Value‑based budget strategies and drafting clinical site budgets, negotiating and implementing contracts, confidentiality disclosure agreements, indemnity/insurance documentation, and amendments, ensuring financial and legal alignment through collaboration with internal and external stakeholders, and maintaining accurate contract data in systems to support effective planning and forecasting.

Payment Oversight

• Strategically oversee the payment processes, escalations, and reporting, ensuring financial/regulatory contract compliance and participating in planning, management, and reconciliation of financial activities.

Qualifications

• Degree (MD, PhD, MA/MSc, BA/BS) in life sciences or equivalent. Postgraduate degree or master’s degree highly desirable.
• Demonstrated experience in clinical trial start‑up, regulatory submissions, and cross‑functional collaboration.
• Strong understanding of ICH‑GCP, EU CTR, and local regulatory environments.
• Experience managing vendor/CRO relationships.
• Proven leadership or line management experience (for PLs).

Skills & Competencies

• Excellent communication and interpersonal skills.
• Strong organisational, analytical, and problem‑solving capabilities.
• Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.).
• Collaborative and adaptable mindset with attention to detail.
• Ability to lead through complexity and ambiguity, especially in matrixed and global teams.
• Fluency in written and spoken English is mandatory.
• Fluency in written and spoken language(s) of the host country is mandatory.

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.