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- Tasks: Ensure data quality and integrity in clinical studies while adhering to industry standards.
- Company: Join a leading clinical biomarker laboratory focused on innovation and excellence.
- Benefits: Enjoy comprehensive healthcare, generous paid time off, and unique family-building support.
- Other info: Dynamic work environment with opportunities for personal and professional growth.
- Why this job: Make a real impact in the pharmaceutical industry with your expertise in data quality.
- Qualifications: 3+ years in clinical labs, strong attention to detail, and team collaboration skills.
The predicted salary is between 40000 - 50000 £ per year.
Adhere to analytical data quality and integrity standards in accordance with MHRA, ICH, and GCP requirements, applicable regulations, and established SOPs across clinical studies.
Verify that transferred data accurately reflect approved and finalized laboratory results and comply with study-specific and sponsor-defined requirements.
Verify compliance of electronic records and electronic signatures with 21 CFR Part 11, EU Annex 11, and internal data governance requirements.
Here’s What You’ll Need (Basic Qualifications)- 3+ years of relevant clinical laboratory experience in the pharmaceutical industry or CROs including data analysis and QC review of data.
- Demonstrated experience performing independent QC review of complex analytical datasets, including reconciliation between raw data, processed results, and reported outputs.
- Knowledge in various lab-based techniques such as LC/MS, immunoassays, cell-based assays, cytometry, and other platforms for the investigation of biomarkers in clinical phase studies.
- Knowledge of Bioanalytical Method Validation for Industry is preferred.
- Knowledge of data management tools, electronic systems, and data integrity requirements.
- Previous experience working in GxP regulated laboratory is highly preferred.
- Hands-on experience and knowledge of quality systems and regulatory requirements (Medicines for Human Use (Clinical Trials) Regulations 2004-SI 2004 No. 1031 as amended, the ICH Guideline for Good Clinical Practice E6(R3), and the Good Clinical Laboratory Practice guidelines: EMA/INS/GCP/532137/2010 and WHO, 2009).
- Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.). Proficiency with statistical analysis methodologies is a plus.
- Strong attention to detail, sound judgment, organizational ability, a team player attitude, and effective written and verbal communication skills.
- Ability to work effectively in a team environment while managing multiple concurrent projects and priorities.
- Ability to work independently while taking direction and adapting to changing study and business needs.
(Fixed Term) Data Quality Control Specialist. Clinical Biomarker Laboratory employer: Moderna Therapeutics
Contact Detail:
Moderna Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land (Fixed Term) Data Quality Control Specialist. Clinical Biomarker Laboratory
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We can’t stress enough how personal connections can open doors that applications alone can’t.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your skills and experiences. We want you to shine, so practice common interview questions and have your own ready to show your interest!
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work or projects that highlight your data quality control skills. We love seeing real-life applications of your knowledge, especially in clinical settings.
✨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 our team at StudySmarter. Let’s get you that job!
We think you need these skills to ace (Fixed Term) Data Quality Control Specialist. Clinical Biomarker Laboratory
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in clinical laboratories and data quality control. We want to see how your skills align with the job description, so don’t be shy about showcasing your expertise in analytical datasets and compliance with regulations.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about data quality in clinical studies and how your background makes you a perfect fit for our team. Keep it engaging and personal – we love to see your personality come through!
Showcase Your Attention to Detail: Given the nature of the role, it’s crucial to demonstrate your attention to detail. Whether it’s in your CV or cover letter, make sure there are no typos or formatting issues. We appreciate candidates who take pride in their work and present themselves professionally.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the information you need about the role and our company culture there!
How to prepare for a job interview at Moderna Therapeutics
✨Know Your Regulations
Familiarise yourself with the key regulations like MHRA, ICH, and GCP. Be ready to discuss how your experience aligns with these standards, especially in relation to data quality and integrity.
✨Showcase Your Technical Skills
Prepare to talk about your hands-on experience with lab techniques such as LC/MS and immunoassays. Highlight specific projects where you performed QC reviews and reconciled complex datasets.
✨Demonstrate Attention to Detail
During the interview, provide examples that showcase your strong attention to detail. Discuss how this skill has helped you maintain compliance with data governance requirements in previous roles.
✨Be a Team Player
Emphasise your ability to work effectively in a team environment. Share experiences where you collaborated on multiple projects, adapting to changing needs while ensuring high-quality outcomes.