Clinical Research Engagement Lead and Study Start Up Lead - fixed term
Roche · Budapest, Hungary
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The PositionThe Opportunity
Are you ready to shape the future of clinical research and make a direct impact on patients' lives?
As a Clinical Research Engagement Lead (CREL) and Study Start Up Lead (SSUL), you will play a pivotal role in strengthening site engagement and driving seamless clinical trial execution across Roche’s portfolio in Hungary. You will act as the primary operational connector between Roche, clinical sites, and Contract Research Organisations (CROs), ensuring our trials deliver with speed, efficiency, and the highest quality standards.
In this dynamic dual role, you will lead site engagement strategies while also driving efficient study start-up processes across various therapeutic areas. By building trust and fostering long-term collaborative partnerships with key operational stakeholders, you will help position Roche as a preferred partner of choice in clinical operations.
Please note that this is a fixed term position with the end date of 31 May 2028.
Clinical Research Engagement Lead (CREL) Responsibilities:
- Drive Strategic Site Engagement: Develop and execute country-level site engagement strategies across disease areas, aligning local priorities with global clinical operational goals.
- Build Strategic Site Partnerships: Deepen relationships with investigators and key operational stakeholders (e.g., pharmacists and clinical administration) to co-create solutions and enhance overall site satisfaction.
- Serve as Primary Point of Contact: Act as the local Clinical Operations Primary Point of Contact (PPOC) and escalation point for cross-study challenges, driving rapid resolution.
- Provide Study & CRO Oversight: Collaborate closely with CRO partners to oversee site monitoring performance, risk-based monitoring plans, eTMF completeness, and inspection readiness.
- Champion Portfolio Execution: Plan and execute country study goals, providing global teams with country-level feedback while proactively managing risk mitigations.
Study Start Up Lead (SSUL) Responsibilities:
- Lead Country Start-Up Strategy: Drive efficient country-level start-up operations to ensure timely site activation, ethics board, and health authority interactions.
- Manage Regulatory & ICF Workflows: Architect Informed Consent Form (ICF) management and oversee clinical trial submissions, amendments, and regulatory packages throughout the trial lifecycle.
- Direct Budgeting & Contracting: Develop Fair Market Value-based budget strategies, draft site budgets, and negotiate contracts and indemnity documentation.
- Oversee Payments & Site Compliance: Strategically oversee payment processes, manage local vendor coordination, and ensure adherence to country-specific regulations.
- Drive Innovation & Automation: Identify opportunities for process standardization, workflow automation, and regional cross-functional alignment to accelerate trial start-up timelines.
Who You Are
- Educational Background: University degree (MD, PhD, MSc, or BSc) in life sciences or an equivalent discipline.
- Industry Expertise: Proven track record in pharmaceutical clinical operations, with end-to-end clinical trial development expertise and thorough knowledge of clinical trial regulations.
- Relationship Management: Demonstrated success in managing site relationships, overseeing complex trials, and collaborating effectively with CROs and cross-functional teams.
- Study Start-Up Proficiency: Hands-on experience with regulatory submissions, site documentation, budgeting, and clinical contract negotiations.
- Language & Mobility: Fluency in both written and spoken Hungarian and English is mandatory, along with a willingness to travel domestically to study sites as required.
Location: This position is based in Hungary.
Relocation Assistance is not avilable
Who we areA 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.