Senior Clinical Data Specialist at Roche

Motherwell, Scotland, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

23 Aug, 26

Salary

0.0

Posted On

25 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, Data Architecture, Regulatory Compliance, ICH-GCP Guidelines, Clinical Database Software, Project Leadership, Cross-functional Collaboration, Mentoring, Data Quality Review, CRF Design, DMP Creation, Resource Planning

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 At Roche Diagnostics Solutions (RDS), our mission is clear: to diagnose earlier, develop faster, and personalise treatment because every patient is unique. Our Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally. We see ourselves and our customers as a team that can only reach its full potential together. By listening closely to patients and physicians, and leveraging digitalisation and new technologies, we get closer to their real-world needs. This collaborative spirit creates an environment where ideas can grow and new ways of doing things can be tried - resulting in competitive products that get to patients faster. Our work spans the entire product lifecycle, from discovery to post-launch. By collaborating with internal teams, external partners, and patients, the CDMA chapter provides crucial medical insights, designs and executes clinical studies, and offers on-market support. Ultimately, we generate the comprehensive clinical evidence that demonstrates product safety, effectiveness, and scientific validity - facilitating smooth product registration, adoption and reimbursement globally so we can save lives and improve patient quality of life. The Opportunity At Roche, we believe care should start before disease takes hold. As a Senior Clinical Data Specialist within our Clinical Operations team, you will perform expert-level data management activities that directly enable innovation, data-driven insights, and continuous improvement across our clinical and development projects. In this pivotal role, you will ensure the delivery of complete, accurate data ready for analysis and regulatory submission, helping us deliver life-changing healthcare solutions faster and more efficiently. Key Responsibilities: Lead Complex Projects: Function as the Lead Data Manager (LDM) and primary point of contact for clinical data management issues, guiding data management teams on large-scale programs and managing timelines and resource planning. Define Data Architecture: Use your professional expertise to define study-specific data workflows, clinical database requirements, and create comprehensive data management documentation (including CRFs, DMPs, database specifications, and data transfer specifications). Ensure Data Excellence: Oversee data quality by defining performance metrics, analysing trends, and performing expert data reviews to identify and resolve incomplete or discrepant data. Collaborate Cross-Functionally: Represent Data Management in cross-functional study team meetings, providing technical clarification and fostering strong partnerships across departments. Mentor and Coach: Drive departmental excellence by mentoring team members, sharing best practices, and supporting the implementation of new technologies. Who You Are You are a collaborative, analytical problem-solver who thrives in a dynamic environment and excels at translating complex technical data concepts for non-technical colleagues. You bring strong professional judgment, a dedication to data quality, and a passion for mentoring others to reach their full potential. To be successful in this role, you bring: Educational Background: A Bachelor’s or Master’s degree in a scientific discipline. Clinical Data Expertise: Extensive, progressive experience in clinical data management with a comprehensive understanding of the clinical study process. Regulatory Knowledge: A solid understanding of regulatory and ICH-GCP guidelines applicable to clinical data management. Technical Proficiency: Experience working with major clinical database software (such as Medrio, RAVE, etc.) alongside relevant computer software (e.g., Google and Microsoft products). Collaboration: Coaching and cross-functional communication skills, with the ability to interact effectively across all levels of an organisation. Ready to make a difference? Apply today and help us shape the future of healthcare! Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Burgess Hill. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process. 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

Lead complex clinical data management projects as the primary point of contact, defining data architecture and workflows. Ensure data excellence and regulatory readiness for analysis and submission while mentoring team members.