Study Systems Lead at F. Hoffmann-La Roche Ltd - Poland

, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

16 May, 26

Salary

0.0

Posted On

15 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Study Systems Lead, Clinical Trial Delivery, IRT/IxRS, eCOA/ePRO, System Implementation, Process Management, Vendor Management, UAT, Change Management, Quality and Compliance, GCP/GVP Compliance, Data Integrity, Regulatory Guidelines, Mentoring, Coaching, Global Infrastructure Projects

Industry

Biotechnology Research

Description

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 The Pharma Product Development (PD) Global Clinical Operations (PDG) team is committed to realizing Roche’s bold ambition of delivering 20 transformative medicines by 2029. Joining our Clinical Operations Excellence group means you'll be a key driver in enhancing the speed and efficiency of clinical trial delivery, directly impacting patients' lives globally. We are a dynamic, enterprise-focused team that values innovation, collaboration, and collective success in a high-performing culture. The Opportunity Your primary mission as a Study Systems Lead - Global Clinical Operations Excellence Manager will be to drive impact, enhance productivity, and enable seamless, efficient clinical trial delivery for patients, investigators, and clinical site staff. Responsible for the implementation of program aligned study systems such as IRT/IxRS and eCOA/ePRO, overseeing process management and monitoring performance in collaboration with program leadership. IxRS and eCOA design, build and UAT ; Evaluate and implement system enhancements throughout study lifecycle Oversight of IxRS and eCOA study vendor, system performance and issue escalation Lead the identification and implementation of continuous improvement and change management activities, offering new perspectives to solve complex operational problems. Apply subject matter expertise in one or more areas—including Quality and Compliance, Business Process, or Knowledge Management—to address emergent, high-impact needs across Clinical Operations. Take accountability for GCP/GVP compliance, business process ownership, and data integrity, ensuring adherence to global and local regulatory guidelines. This role offers significant global influence and impact, with the opportunity to mentor and coach colleagues and lead parts of global infrastructure projects. Who you are: You are an established professional with a comprehensive working knowledge of the infrastructure needed to conduct clinical trials, ready to take on complex challenges and drive strategic change. Typically, you have proven experience in clinical trial operations in process, compliance, audit and inspections, vendor management, systems, or learning. Demonstrated subject matter expertise on specific clinical operations infrastructure activities and experience in executing global clinical trials infrastructure projects. You possess and can apply proficient knowledge of ICH, GCP, and regulatory guidelines within clinical trials or enabling activities to ensure strong compliance. Capable of independently prioritizing your own work and effectively influencing the team to develop and execute plans for clinical trial infrastructure projects. You are skilled in solving complex outcomes, taking a new perspective on existing solutions, and exercising judgment based on analyzing multiple sources of information. Experience in mentoring and coaching less experienced colleagues and providing informal guidance is preferred. We look forward to your application. This role is based on site at our Welwyn, United Kingdom office. Our team follows a hybrid work structure, requiring a fixed number of onsite days per week. 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. The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.

Responsibilities

The primary mission is to drive impact, enhance productivity, and enable seamless, efficient clinical trial delivery by being responsible for the implementation of program-aligned study systems like IRT/IxRS and eCOA/ePRO. This includes overseeing process management, monitoring system performance, and leading continuous improvement activities across the study lifecycle.