Clinical Study Manager

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

We advance science so that we all have more time with the people we love

Your Opportunity

• Provides local strategic planning and organization to achieve successful study completion
• Maintains full ownership of the Affiliate portion of a study and ensures the effective and efficient delivery of country operational aspects in accordance with the study development plan and ICH/GCP standards Roche SOPs, local operating guidelines and local regulatory requirements
• Ensure consistency and standards across study for all Investigational sites
• Proper documentation and archiving of all activities (e.g., IMP management, safety reporting, project milestones, vendors selection and periodic assessment, trainings records, sponsor assessment)
• Timely reporting (e.g., monitoring activities, safety, study status in CTMS)
• Proper execution of budget and timelines of clinical programs
• Planning and execution of investigators meetings, as appropriate
• Contribution to data generating activities for the assigned projects
• Involvement in the execution of protocol and site
• Contribution to local studies set up and relevant documents preparation
• IEC/IRB submissions and site contract negotiation
• Proactively contributes to quantity and effectiveness improvement within the function
• For PA supported studies, ensuring the sponsor conducts the study in compliance with the contract and Roche guidelines
• Ensuring that risk and quality plans are properly in place for each assigned study
• Effectively collaborating with key internal and external stakeholders
• Establishing and meeting country level commitment regarding study timelines, patient recruitment, budget
• Ensure adequate tracking of the relevant information into the dedicated company tools/systems
• Conducting protocol and site feasibility
• For local studies (PA), provides leadership of the SMT and overall operational management including study document and materials preparation (i.e., protocol CRF, CSR, publications) site selection and patient recruitment
• Coordinating investigators and steering committee
• Performing/supporting IRB/IEC submission and contract negotiation
• Ensuring SAE
• Reconciliation
• Develop risk assessment and quality plans
• Ensuring all assigned studies are undertake in accordance to ICH/GCP standards, Roche SOPs and quality standards, local operating guidelines and local regulatory requirements
• Communicating critical issues properly and ensuring they are solved on time
• Providing Global Teams with feedback from an Affiliate perspective
• Development of partnerships with local businesses
• Development of relationship with investigators and OLS
• Accountable to ensure that the study team is duly trained and qualified
• Identifying and sharing areas of best practice and process improvements
• Collaborating in the preparation of audits and inspections and ensuring adequate CAPA follow up
• Assure consistency and standards (of both process and project) across clinical programs for all investigational sites and staff involved in study management

Who you are

• University degree or equivalent in a medical/ pharmacy/science-related field
• Proven significant Clinical Research/Development or related industry experience on the
• operational aspects of conducting clinical studies including vendor/CRO management
• leading/working as part of a development team, implementing clinical development plans,
• coordinating study level activities to deliver data for filing or publication purposes
• Demonstrate ability to prioritize and manage multiple tasks simultaneously
• Project management experience including implementation of risk management plans and
• management of complex study budgets and resourcing plans
• Complete knowledge of ICH GCP Roche SOPs/ Guidelines and Quality standards related to
• study management
• Detailed knowledge of all operational aspects of Clinical Trial Management
• Knowledge of the assigned therapeutic areas
• Ability to communicate clearly and accurately in both written and spoken English
• Decision making- able to make sound, timely decisions within areas of own responsibility and
• recognize when and how other stakeholders need to be involved
• Collaboration and teamwork-successful and comfortable working in a complex national and
• international multi-functional matrix through all stages of clinical studies
• Project management-successful record of accomplishment of managing high performing
• study teams is preferred. Experience in influencing and negotiating to achieve team delivery
• Communication- good written and verbal communication skills demonstrated by an ability to
• interact with different teams within the research community
• Personal organization- self-motivated and achievement driven, highly organized, excellent
• ability to prioritize own tasks and to optimize team performance
• Cost and financial awareness-ability to manage complex study budget

What we offer

Roche offers rewarding growth opportunities, a competitive remuneration package and a collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders. 

Roche encourages a high-performance culture where you are empowered and trusted to make decisions. We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients.

Take pride in knowing you can make a difference to millions of patients worldwide in developing diagnostics and treatments for oncology, neuroscience, inflammation, immunology, ophthalmology, rare diseases, respiratory disease and diabetes.

We are committed to providing an inclusive, safe, secure and healthy workplace, and to minimise any such impacts to our employees, customers and the community. We welcome applications from all people and encourage you to advise of any individual circumstances that may require consideration.

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.