At a Glance
- Tasks: Lead clinical operations and manage contracts for impactful health projects.
- Company: GSK, a global biopharma company with a mission to improve health.
- Benefits: Hybrid working, career growth, and a chance to make a real difference.
- Other info: Inclusive workplace with opportunities for personal and professional development.
- Why this job: Join a team dedicated to transforming lives through innovative medicines and vaccines.
- Qualifications: Bachelor’s degree or relevant experience in clinical operations required.
The predicted salary is between 37052 - 45286 £ per year.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives.
As Clinical Operations Specialist (Contracts), you will lead the co-ordination and delivery of specialised operational activities according to ICH GCP, international and local regulations, and relevant GSK written standards. You will play a pivotal role as a member of the local clinical study team and are responsible for contributing to the planning, execution, and delivery of the Clinical trial in the country.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Contracts and Other Legal Documents
- Responsible for coordinating and controlling contracts and other legal documents for clinical operations, communicating updates, and documenting activities in accordance with GSK SOPs and local legislation in-country and for CRO-managed Country/ies where applicable.
- Accountable for negotiation and execution of investigator and supplier contracts and amendments.
- Responsible for ensuring all contractual terms and conditions are based on the approved GSK Master template.
- Develop and maintain accurate tracking information related to contracts, CDAs, compensation clauses, and external costs.
- Acts as clinical operations expert/point of contact on any contracting/legal issues, SOP interpretation, dispute resolution and proactively identifies areas of risk to Management.
- Develops training materials and actively train/coach/mentor staff on contracting procedures/processes applicable to clinical research.
- Lifecycle Oversight
- Own the entire contract lifecycle – intake, version control, execution, performance tracking, renewals, and termination – using modern Contract Lifecycle Management (CLM) tools.
- Budget Development and Negotiation
- Responsible for reviewing benchmarking and historical data to complete the study budget build in collaboration with the Local Delivery Lead.
- Responsible for leading the budget development and negotiation process with the site or supplier, ensuring fair market value and consistency while optimizing cost and minimizing risk.
- Acts as consultant/expert resource with respect to study budget development and any associated systems/tools, including identifying cost variances and opportunities for cost avoidance.
- Other Clinical Operation Specialist Responsibilities
- Responsible for coordinating and updating information required for institutional reports and external stakeholders.
- Could act as subject matter expert at the LOC for different applications applicable to their role.
- Provide administrative support to the local GMASE department by coordinating meetings, managing communication flows, acting as the liaison between local and global teams, and performing related administrative duties.
This role is offered as hybrid working. You will combine remote work with regular time in a UK office and occasional site visits.
We are seeking professionals with the following required skills and qualifications:
- Bachelor’s degree, or equivalent, or relevant experience in clinical operations or similar positions in the pharmaceutical industry.
- Solid knowledge of ICH-GCP, local regulations, and regulatory processes.
- Experience in the UK National Contract Value Review (NCVR) process and proficiency with the CPMS platform.
- Excellent understanding of the external clinical trial environment and UK clinical trials regulations and start-up processes.
If you have the following characteristics, it would be a plus:
- Enthusiasm for AI-enabled tools and digital solutions to improve efficiency, data quality, and decision-making in clinical trial operations.
- Strong communication skills and relationship management abilities.
We welcome people from different backgrounds and life experiences. We support an inclusive workplace where everyone can contribute and grow. We look for colleagues who act with integrity, communicate openly and help each other succeed.
If this role matches your skills and ambitions, we encourage you to apply. Tell us how your experience fits the role and let our recruitment team know if you need adjustments during the process.
Clinical Operations Specialist (NCVR & Contracts) employer: GlaxoSmithKline
GlaxoSmithKline is an exceptional employer, offering a dynamic work environment that fosters innovation and collaboration in the pharmaceutical industry. With a strong commitment to employee development, you will have access to numerous growth opportunities while enjoying a competitive salary, annual bonus, and a flexible hybrid working model that promotes work-life balance. Located in the UK, GSK's culture prioritises teamwork and inclusivity, making it a rewarding place for professionals passionate about making a difference in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Operations Specialist (NCVR & Contracts)
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We think you need these skills to ace Clinical Operations Specialist (NCVR & Contracts)
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at GlaxoSmithKline!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show GlaxoSmithKline that you're not just a fit for the job but also a safety-conscious candidate!
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Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At GlaxoSmithKline, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at GlaxoSmithKline
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at GlaxoSmithKline that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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Take some time to familiarise yourself with GlaxoSmithKline’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
