Associate Clinical Study Lead – Companion Diagnostics
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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.
We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you.
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
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
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 (eg. 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 (<5%)
What we offer
Attractive pension
Private Healthcare and Dentalcare
Gym membership contribution
A range of retail discounts and offers
Enhanced maternity package
Flexible working options
Bonus/commission
25 days annual leave (potential to increase linked to service)
Employee Assistance Program and internal QIAGEN communities
Hybrid work (conditional to your role)
Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.
QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualif