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The Position
Role Purpose
The Medical Affairs Clinical Operations Lead (MA COL) is a critical execution role within Medical Affairs, mainly responsible for providing operational support for affiliate-executed medical affairs programs. This role focuses on the execution, coordination, and quality oversight of RWE activities, Investigator-Initiated Studies (IIS), and Post Trial Access (PTA) ensuring all programs are conducted according to Roche quality standards, applicable regulations, timelines, and budget commitments.
Core Responsibilities
- Operational Execution for
- Provide day-to-day operational support for assigned Medical Affairs evidence-generation programs, with a primary focus on RWE activities and Non-Interventional Studies (NIS)
- Assist in the execution and tracking of study milestones from study start-up through conduct and close-out
- Support the management of study documentation, including the Trial Master File (TMF/eTMF), to ensure completeness and inspection readiness
- Be responsible for administrative, financial tracking, and logistical tasks for assigned studies and collaborate with internal stakeholders (e.g., Medical Advisors, RWD Scientists, Finance) to ensure coordinated project delivery
- Feasibility Assessment Support & Act as a SME in the team
- Paring with Medical Advisors, in conducting preliminary feasibility assessments for new evidence generation programs to evaluate operational opportunities, site capacity, and overall study implication
- Support the collection and analysis of country and site-level data necessary for informed operational planning
- Be the consultation in the Medical Affairs team to advise from the operational perspective; be the subject matter expert (SME) to guide and enhance the internal capabilities.
- Quality Oversight and Compliance
- Support the oversight of assigned study activities, including those managed by Contract Research Organizations (CROs) or other external vendors
- Assist in monitoring compliance to study protocols, Roche Standard Operating Procedures (SOPs), and relevant regulations (e.g., ICH-GCP, GPP)
- Support quality control checks of clinical operations documentation and data, escalating quality issues
- Help maintain effective communication with site personnel to support high-quality study execution
Requirements
Qualifications:
- University Degree or equivalent, preferably in a medical, life sciences, or public health-related field
Experience:
- Recommended > 1 years of experience in Clinical Research/Development, Clinical Operations, or a related pharmaceutical/healthcare industry setting (or equivalent academic/internship experience)
- Prior experience or academic exposure to clinical trial processes or medical affairs activities is a plus
Competencies:
- Comprehensive knowledge in clinical operations.
- Strong organizational skills and project management, especially exceptional attention to detail
- Ability to manage multiple tasks and prioritize work efficiently
- Effective written and verbal communication skills in English
- A proactive and collaborative approach to teamwork and problem-solving.
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.
