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 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 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 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.
