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- Tasks: Lead global clinical serology projects and ensure high-quality testing standards.
- Company: Join a leading biotech firm making waves in the clinical industry.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real impact on global health through innovative clinical trials.
- Qualifications: Experience in project management and knowledge of serology/virology assays required.
- Other info: Dynamic team environment with opportunities to work across multiple countries.
The predicted salary is between 36000 - 60000 £ per year.
We are currently searching for a skilled professional to join a well-known client’s team in the role of Sample Management Lab Project Manager. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
MAIN RESPONSIBILITIES AND ACCOUNTABILITIES:
- Responsible for the planning, oversight of testing and reporting of clinical serology across a global portfolio of clinical trials (seasonal, pandemic and another trial as required).
- Provide serology expertise and input to clinical protocol and associated documents.
- Responsible for project managing all aspects of the clinical serology lifecycle, including, but not limited to:
- Sample/swab collection protocols.
- Sample/swab shipment from clinical/investigator sites/depots to external vendor (300+ sites across 15+ countries).
- Ensuring testing is being conducted according to the optimised, validated protocol(s).
- Issue/risk identification and resolution; ensure escalation pathway to Snr/GCOL and/or Program Director, as needed.
- Management of budget for clinical serology testing and retention of samples.
- Responsible for identifying, evaluating and selecting external vendors capable of conducting serology testing supporting pivotal global clinical trials.
- Accountable for oversight of clinical serology vendors and ensuring the quality of data is robust and per validated protocols.
- Responsible for managing clinical serology samples per country regulations and/or informed consent procedures.
- Capability to oversee and manage complex sample collection and shipping processes across global regions (Asia Pacific, Americas (NA and LATAM) and Europe, Middle East and Africa).
- Review validation protocols for clinical serology testing and ensure testing is in compliance with clinical protocol, local regulations and Good Clinical Practice.
- Responsible for sourcing reagents and/or anti-sera from manufacturing facilities, Regulatory Agencies and/or External Reference Laboratories (WHO, CBER, NIBSC, TGA).
- Establishes and maintains close relationships with manufacturing facilities and External Reference Laboratories.
- In collaboration with Research and Technical Development, serology functions drive the optimization of assays and/or changes to testing procedures as requested by Regulatory Authorities.
- Provision of serology expertise in responding to Regulatory Agency questions regarding serology testing.
- Responsible for ensuring contracts with external serology testing and sample storage vendors are executed in a timely manner and are cost-effective.
COMPETENCIES:
- Demonstrated ability to lead teams and work in a fast-paced team environment.
- Experienced in working within a Matrix Environment.
- Excellent interpersonal and decision-making skills.
- Demonstrates innovation.
- Possesses drive, energy, and enthusiasm to deliver the program objectives.
- Specialist knowledge of serology and virology assays related to the analysis of clinical trial samples.
- Established relationships within the World Health Organization (WHO) and other relevant bodies.
- Excellent understanding of all tasks involved in a clinical development program, from developing a protocol to finalizing a clinical study report.
- Ability to plan and ensure execution and completion of serology testing to the highest ethical and scientific standards.
- Demonstrated ability to comprehend complex scientific concepts and data.
- Proficient in reviewing and assessing clinical data.
- Extensive and comprehensive knowledge of ICH guidelines/GCP.
- Maintains current medical/scientific/regulatory knowledge.
- Demonstrated project management skills, including simultaneous management of multiple projects.
- Possesses excellent planning, time management.
Sample Management Lab Project Manager employer: Advanced Clinical
Contact Detail:
Advanced Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sample Management Lab Project Manager
✨Tip Number 1
Network like a pro! Reach out to people in the biotech industry, especially those who work in sample management or clinical trials. A friendly chat can lead to insider info about job openings that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your serology and virology knowledge. Be ready to discuss how you’ve managed complex projects in the past. We want to see your passion and expertise shine through!
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can keep you fresh in the interviewer’s mind. Plus, it shows you’re genuinely interested in the role and the company.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to connect with us directly.
We think you need these skills to ace Sample Management Lab Project Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Sample Management Lab Project Manager role. Highlight your experience in clinical trials, serology expertise, and project management skills. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how you can contribute to our team. Be sure to mention any relevant experiences that showcase your ability to manage complex projects.
Showcase Your Skills: In your application, don't forget to highlight your interpersonal and decision-making skills. We value innovation and enthusiasm, so share examples of how you've demonstrated these qualities in past roles.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people. Good luck!
How to prepare for a job interview at Advanced Clinical
✨Know Your Stuff
Make sure you brush up on your knowledge of serology and virology assays. Be ready to discuss how these relate to clinical trial samples, as this will show your expertise and understanding of the role.
✨Showcase Your Project Management Skills
Prepare examples of how you've successfully managed complex projects in the past. Highlight your experience with sample collection protocols and vendor management, as these are key aspects of the job.
✨Demonstrate Your Interpersonal Skills
Since this role involves working with various teams and external vendors, be prepared to discuss how you've built relationships in previous roles. Share specific instances where your communication skills made a difference.
✨Be Ready for Regulatory Questions
Familiarise yourself with ICH guidelines and Good Clinical Practice. Expect questions about how you would handle regulatory agency inquiries regarding serology testing, and be ready to demonstrate your knowledge.
