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- Tasks: Lead biospecimen management for clinical trials, ensuring compliance and operational excellence.
- Company: Join a leading pharmaceutical company dedicated to innovative healthcare solutions.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real difference in clinical research and contribute to groundbreaking medical advancements.
- Qualifications: Advanced degree in life sciences preferred; relevant experience required.
- Other info: Dynamic work environment with a focus on collaboration and innovation.
The predicted salary is between 46000 - 52000 £ per year.
The Clinical Biospecimen Senior Scientist is responsible for the implementation and end-to-end operational execution of each GCO clinical trial strategy as it relates to all biospecimens collected, including safety, pharmacokinetics, biomarkers for clinical trials of standard to medium complexity, in compliance with Novartis processes and regulatory and ethical requirements.
Key Responsibilities:
- Contribute to all technical and operational biospecimen-related matters for assigned clinical studies of standard to medium complexity, in collaboration with internal stakeholders and line function (LF) representatives.
- Provide input on clinical sample assessment sections in clinical trial-related documents (such as protocols and consents) in collaboration with the LF representatives, including creating study-specific sample collection tables and ensure alignment with blood volumes needed versus allowed.
- Liaise with internal stakeholders to provide input into the SSW’s for all biospecimen collection and testing needs. Set up and oversee the technical aspects for all laboratories involved in kit building, sample management, and testing, including all related documentation such as lab manuals.
- Provide input and solutions on the ethical considerations for biospecimen collections and analyses for protocols and consents to ensure that all specific processes needed for approval in different countries are implemented.
- Responsible for sample management and logistics, with some oversight from the Lead CBS, throughout the biospecimen lifecycle; this includes ensuring timely analysis, proper consent, and oversight of samples, in collaboration with data management.
- Ensure proper handling of all study close out activities related to biospecimens and laboratories, including sample disposition (disposal, return, storage).
- Define sample needs for the case report forms (CRFs) and data transfer in collaboration with internal stakeholders/LF representatives, trial clinical data scientist (TCDS) and analysis labs; with support, liaise with the TCDS and labs for data transfer and data reconciliation.
- Support the development of training material on the technical aspects of biospecimen collections for the clinical trial sites, including study specific lab manuals and additional site and monitor training needs.
- Ensure proper escalation of any identified trial specific risks and issues related to biospecimen collection and analysis in conjunction with relevant line functions.
- Collaborate with vendor management and procurement, with some oversight from the Lead CBS, review all laboratory proposals and provide budget input for the trial forecast; review invoices.
- Implementation of and compliance to standards (SOPs) and best practices within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
Essential criteria:
- Advanced degree in life sciences strongly preferred, BS or BA in life sciences with relevant experience required.
- English language (written and oral).
Desirable criteria:
- Familiarity with standard sample testing methodologies, assay technologies, and molecular biology.
- At least 2 years of experience handling diverse type of clinical samples.
- Knowledge of GCP; intermediate knowledge of GLP and ICH.
- Intermediate knowledge of clinical trial design and the overall drug development process.
- Excellent organizational and communication skills.
- Ability to manage multiple competing priorities and meet timelines.
Skills Desired:
- Budget Management
- Clinical Research
- Clinical Trial Protocol
- Clinical Trials
- Coaching
- Data Analysis
- Data Integrity
- Learning Design
- Lifesciences
- Risk Monitoring
- Trends Analysis
Clinical Biospecimen Senior Scientist employer: Healthcare Businesswomen’s Association
Contact Detail:
Healthcare Businesswomen’s Association Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Biospecimen Senior Scientist
✨Tip Number 1
Network like a pro! Reach out to your connections in the life sciences field, especially those who work in clinical trials. They might know about openings that aren't advertised yet, and a personal recommendation can really give you an edge.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of biospecimen management and clinical trial processes. We recommend practising common interview questions and even doing mock interviews with friends or mentors to boost your confidence.
✨Tip Number 3
Showcase your skills! When you get the chance to meet potential employers, whether at networking events or interviews, be ready to discuss specific examples of your experience with clinical samples and how you've tackled challenges in past projects.
✨Tip Number 4
Don't forget to apply through our website! It’s a great way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive and engaged in their job search.
We think you need these skills to ace Clinical Biospecimen Senior Scientist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical Biospecimen Senior Scientist role. Highlight your relevant experience in handling clinical samples and any specific projects that align with the job description. We want to see how your background fits with what we do!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about biospecimen management and how your skills can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Skills: Don’t forget to highlight your organisational and communication skills, as these are key for this role. Mention any experience you have with clinical trial protocols or sample management to show us you’re the right fit!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just follow the prompts!
How to prepare for a job interview at Healthcare Businesswomen’s Association
✨Know Your Stuff
Make sure you brush up on your knowledge of clinical trials, biospecimen management, and relevant regulations like GCP and GLP. Being able to discuss these topics confidently will show that you're not just familiar with the basics but can also handle the complexities of the role.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific situations related to biospecimen collection and management. Think about past experiences where you had to solve problems or make decisions under pressure, and be ready to share those examples.
✨Show Your Collaborative Spirit
This role involves working closely with various stakeholders. Be prepared to discuss how you've successfully collaborated in the past, whether it was with internal teams or external partners. Highlight your communication skills and ability to manage competing priorities.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the role and the company. Inquire about their current clinical trials, challenges they face in biospecimen management, or how they ensure compliance with ethical standards. This demonstrates your enthusiasm and proactive mindset.