Study Start-Up Lead

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The Position

Job summary - 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 (CT) 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 and Accountabilities

This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by developing and implementing effective start-up strategies, overseeing start-up operations, and driving process improvements at the country and site level while maintaining regulatory compliance.

Key responsibilities include:

• 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, standardization, and innovation.

• Collaborating with regional and global counterparts to harmonize 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 Committees (EC), Health Authorities (HA)).

You will lead in a cross functional environment in multiple of the following areas below, with specific focus on Submissions to HA/EC, Site Documentation and Financial aspects:

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 the 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.

Additional responsibilities

• Responsible for tasks assigned or agreed by Line Manager, in line with flow to work concept and flexibility.

Qualifications

• Degree (MD, PhD, MA/MS, 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

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.