Associate Clinical Study Lead – Companion Diagnostics in Manchester
Associate Clinical Study Lead – Companion Diagnostics

Associate Clinical Study Lead – Companion Diagnostics in Manchester

Manchester Full-Time 36000 - 60000 £ / year (est.) No home office possible
QIAGEN

At a Glance

  • Tasks: Support planning and execution of clinical studies in oncology and biopharma.
  • Company: Join QIAGEN, a leader in revolutionising science and healthcare globally.
  • Benefits: Enjoy private healthcare, gym contributions, flexible working, and 25 days annual leave.
  • Why this job: Make a real impact in healthcare while growing your career in clinical affairs.
  • Qualifications: Bachelor's in life sciences and experience in clinical affairs required.
  • Other info: Collaborative environment with opportunities for personal and professional growth.

The predicted salary is between 36000 - 60000 £ per year.

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 have 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 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

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 qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.

Associate Clinical Study Lead – Companion Diagnostics in Manchester employer: QIAGEN

At QIAGEN, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. With a strong commitment to employee growth, we offer comprehensive benefits including private healthcare, flexible working options, and opportunities for professional development. Located in vibrant cities like Manchester and Barcelona, our teams thrive in diverse environments where every day presents a chance to make a meaningful impact in the fields of science and healthcare.
QIAGEN

Contact Detail:

QIAGEN Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Associate Clinical Study Lead – Companion Diagnostics in Manchester

Tip Number 1

Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.

Tip Number 2

Prepare for interviews by researching QIAGEN and understanding their mission. Tailor your answers to show how your skills align with their goals in revolutionising science and healthcare.

Tip Number 3

Practice makes perfect! Conduct mock interviews with friends or use online resources to refine your responses. The more comfortable you are, the better you'll perform when it counts.

Tip Number 4

Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining the QIAGEN team.

We think you need these skills to ace Associate Clinical Study Lead – Companion Diagnostics in Manchester

Clinical Study Planning
Budget Tracking
Stakeholder Communication
Study Documentation Preparation
Regulatory Knowledge (FDA CFR, ICH GCP, ISO14155, ISO20916, ISO13485, IVDR, CLSI guidance)
Site Management Coordination
eTMF Experience (e.g. Veeva)
Clinical SOP Writing
Cross-Functional Collaboration
Problem-Solving Skills
Attention to Detail
Organisational Skills
Proactive Approach
Ability to Travel

Some tips for your application 🫡

Tailor Your Application: Make sure to customise your CV and cover letter for the Associate Clinical Study Lead role. Highlight your relevant experience in clinical affairs and any specific skills that match the job description. We want to see how you can contribute to our mission!

Showcase Your Passion: Let your enthusiasm for science and healthcare shine through in your application. Share why you're excited about the opportunity to work with QIAGEN and how you can make a real-life impact. We love seeing candidates who are genuinely passionate about what they do!

Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language and avoid jargon unless it's relevant. We appreciate a well-structured application that makes it easy for us to see your qualifications and fit for the role.

Apply Through Our Website: Don’t forget to submit your application through our official website! It’s the best way for us to receive your details and ensures you’re considered for the position. Plus, it shows you’re serious about joining our team at QIAGEN!

How to prepare for a job interview at QIAGEN

Know Your Stuff

Make sure you brush up on your knowledge of Companion Diagnostics and the specific clinical study processes mentioned in the job description. Familiarise yourself with relevant regulations like FDA CFR and ICH GCP, as well as any specific tools like eTMF systems. This will show that you're not just interested in the role, but that you understand the industry.

Show Your Collaborative Spirit

Since QIAGEN values collaboration, be ready to share examples of how you've worked effectively in teams. Think about times when you coordinated with different stakeholders or managed cross-functional projects. Highlighting your ability to communicate and work well with others will resonate with their team-oriented culture.

Prepare for Scenario Questions

Expect questions that ask how you'd handle specific situations, such as managing timelines or dealing with unexpected issues during a study. Prepare by thinking through potential challenges in clinical studies and how you would address them. This will demonstrate your proactive approach and problem-solving skills.

Ask Insightful Questions

At the end of the interview, have a few thoughtful questions ready about the role, team dynamics, or future projects at QIAGEN. This shows your genuine interest in the position and helps you assess if the company is the right fit for you. Plus, it gives you a chance to engage with the interviewers on a deeper level.

Associate Clinical Study Lead – Companion Diagnostics in Manchester
QIAGEN
Location: Manchester

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