Clinical Research Engagement Lead and Study Start Up Lead - fixed term
Employer · Roche
Other health professional
R&D manager
Health services managerTemporaryBudapest
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).
Tasks
- 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 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
- 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
Requirements
- University degree (MD, PhD, MSc, or BSc) in life sciences or an equivalent discipline
- Proven track record in pharmaceutical clinical operations, with end-to-end clinical trial development expertise and thorough knowledge of clinical trial regulations
- Demonstrated success in managing site relationships, overseeing complex trials, and collaborating effectively with CROs and cross-functional teams
- Hands-on experience with regulatory submissions, site documentation, budgeting, and clinical contract negotiations
- Fluency in both written and spoken Hungarian and English is mandatory, along with a willingness to travel domestically to study sites as required