Associate Clinical Study Lead – Companion Diagnostics in Manchester

Overview
At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible. We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we’ve grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams. At QIAGEN, every day is an opportunity to make a real-life impact. Join us, grow with us, and together, let’s shape the future of biological discovery.

About the opportunity
Join QIAGEN as an Associate Clinical Study Lead (CSL) and play a key role in supporting the successful planning, execution, and delivery of QIAGEN-sponsored clinical studies. In this role you will contribute to the advancement of Companion Diagnostics programs within Oncology and Biopharma. This role is ideal for someone eager to grow within clinical affairs, take ownership of study activities, and work closely with internal and external stakeholders across global environments. The position can be based in Manchester (UK) or Barcelona (Spain).

Your tasks

• Support study planning activities by helping prepare timelines, gather resource needs, and assist with budget tracking for QIAGEN-sponsored clinical studies.
• Coordinate day-to-day clinical study activities with internal teams, external partners, laboratories, and vendors. Provide regular status updates and help ensure smooth communication across all stakeholders.
• Assist in preparing study documentation, such as draft protocols, informed consent forms, investigator brochures, contracts, and reports. Ensure documents follow relevant regulations, guidelines, and internal SOPs.
• Help monitor and track ongoing studies, checking progress against timelines and budgets. Flag potential issues to senior team members and help organise meetings for troubleshooting and planning.
• Support site selection and setup, including gathering site feasibility information, coordinating site preparation, ensuring required equipment or materials are available, and helping organise training in line with the clinical protocol and SOPs.
• Coordinate with clinical research associates (CRAs) and other team members to support site management activities. Assist with scheduling and hosting site visits and help prepare for audits or QC checks.
• Support regulatory activities by gathering required documents, coordinating communication with regulatory teams, and assisting with submissions for the regions involved (e.g., EU/EEA or USA).
• Assist with study close-out procedures, including organising study files, managing study supplies, and coordinating with CTAs, CRAs, data management, and statistics teams on close-out documentation.
• Help draft sections of clinical study reports and submission materials for regulatory bodies, IRBs, or local agencies, and assist in compiling responses to queries.

Your profile

• A bachelor's degree in a life science or health-related field (e.g., biology, biomedical science, nursing, chemistry, public health).
• Employment experience in a clinical affairs position such as CRA, CTA.
• Proven experience with eTMF (e.g. Veeva).
• Experience of writing clinical SOPs.
• Knowledge of relevant regulatory requirements and industry working practices e.g. FDA CFR, ICH GCP, ISO14155, ISO20916, ISO13485, IVDR, CLSI guidance, design control.
• A pro-active, collaborative approach with the ability to work in a cross-functional, team-based environment.
• Ability to travel occasionally to clinical sites.