At a Glance
- Tasks: Lead biosample operations for clinical studies, ensuring quality and compliance throughout the process.
- Company: Join a leading pharmaceutical company focused on innovative healthcare solutions.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic role with potential for career advancement in a collaborative environment.
- Why this job: Make a real impact in clinical research while working with cutting-edge biosample management.
- Qualifications: Bachelor’s degree in Life Sciences and 6+ years in Clinical Operations required.
The predicted salary is between 60000 - 80000 £ per year.
Senior Manager, Biosamples Operations Lead will own end-to-end biosample operations across assigned studies/programs – from operational feasibility, vendor selection, and execution of biosample operations activities through analysis and data delivery.
- Main Responsibilities
- Provides strategic and expert input for the operational feasibility, implementation and execution of the biosample operations activities in assigned clinical studies/programs.
- Manages biosample management activities in clinical studies with low to moderate complexity, risk, impact and reach.
- Accountable for planning, implementation and execution of biosample operations activities, ensuring proactive risks and issues management and alignment with overall clinical study timelines.
- Owns biosample operations plan and is responsible for its maintenance and adjustments during clinical study conduct.
- Leads cross‑functional biosample operations team and manages team meetings to review status of biosample operations activities, discuss risks/issues and agree on appropriate mitigation.
- Acts as the single point of contact (POC) in the Study Team on biosample operations related aspects (including biomarker and bioanalytical activities).
Ensures timely status updates and escalation of risks/issues to the clinical Study Team.
- Contributes to central lab or assay lab vendor selection and qualification.
- Oversees central lab set‑up, kit management, and ongoing study‑level vendor performance.
- Manages CRO and central lab interfaces to ensure cross‑functional alignment on deliverables.
- Maintains a patient‑focus approach while delivering the complex requirements of a clinical study, balancing patient burden, sampling requirements, the complexity of collection and the cost implications.
- Responsible for overseeing the biosample lifecycle and compliance to ensure that the biosamples are collected, processed, analysed and stored with the highest degree of quality and according to applicable regulations.
- Reviews and provides input to protocols, ICFs, lab manuals, and regulatory submissions.
- Leads budget planning & forecasting for biosample activities of assigned studies.
- Ensures all activities comply with ICH‑GCP, GCLP, biobanking policies, and applicable ethical standards.
- Leads audit and inspection readiness; act as interviewee and prepare regulatory responses.
- Impacts the successful delivery of a program/study and ensures optimized execution of the biosample/biomarker operations strategy on time, within budget and required quality.
- Leverages strategic operational knowledge and serves as subject‑matter expert for current biosample management processes and regulations.
- Required Skills and Education
- Minimum Bachelor’s degree in Biology, Pharmaceuticals, or Life Sciences or related field.
- At least 6+ years of experience in Clinical Operations with a focus on biosample management activities in a CRO or pharma setting.
- Proven track record in central lab oversight, vendor management, and Phase I–III biosample logistics.
- Experience in CDx development and/or bioanalytical requirements would be advantageous.
- Broad experience across multiple therapeutic areas, trial phases and biosample lifecycle management.
- Comprehensive and working knowledge of GCP, GCLP guidelines and other relevant regulations and requirements for the collection, analysis and storage of clinical biosamples.
- Very good knowledge of biosample management related systems and technologies (LIMS, BRICK, CTMS, etc).
- Demonstrated experience in effectively collaborating with other functions in a complex matrix organization.
- Very good command in English language.
- Additional Information
Please note this role is not eligible for the UK visa sponsorship.
Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered.
Any applications from candidates based outside of these locations will not be considered.
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Senior Manager Biosamples Operations Lead in Reading employer: IQVIA
IQVIA in Livingston, Scotland is an excellent employer that fosters a collaborative team environment and prioritises employee growth through outstanding career development opportunities. Working as a Lab Operations Assistant here not only allows you to contribute to meaningful projects but also ensures you are part of a supportive workplace that values safety and professionalism.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager Biosamples Operations Lead in Reading
✨Get Involved in Local Research Communities
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We think you need these skills to ace Senior Manager Biosamples Operations Lead in Reading
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show IQVIA that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at IQVIA.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that IQVIA does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at IQVIA
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at IQVIA. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into IQVIA's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at IQVIA. This shows your passion for the industry!
