Study Start Up Lead

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

Key Responsibilities

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 Boards Health Authorities).

You will lead in a cross functional environment in multiple of the following areas below:

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.

Qualifications

Degree (MD PhD MA/MS BA/BS) in life sciences or equivalent. Postgraduate degree or masters 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

Skills & Competencies

Excellent communication and interpersonal skills

Strong organizational 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.

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.