Clinical Operations Specialist (Logistics & Supplies)

As Clinical Operations Specialist (Logistics & Supplies), 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 offers visible career growth, a chance to shape ways of working, and meaningful impact while uniting science, technology and talent to get ahead of disease together.

• Accountable for facilitating timely and secure delivery of clinical trial material, ancillary study supplies and devices to clinical sites in collaboration with suppliers, local depot, customs brokers, couriers, and GSK teams.

May prepare and/or review importation documentation and maintain oversight of supply logistics, including cold chain requirements.

May also be responsible for export of supplies or equipment and IMP distribution/destruction via local depot.

• Responsible for oversight of vendor(s) managing local clinical supplies storage, supply distribution and destruction.

May be required to purchase clinical trial supplies locally.

Works with procurement and prepares purchase orders or task orders for services and supplies.

Acts as business owner for local contracts and purchase orders related to clinical and ancillary supplies and IMP local depot where applicable.

As needed, coordinates the support of clinical support specialists in preparation, tracking system updates and filing of documents.

• Maintain expert knowledge of requirements for importation and distribution of supplies according to local regulations and manufacturer requirements, ensuring the necessary operational processes are in place.

Acts as the in-country single point of contact for local and central study team questions related to clinical trial supply importation and logistics.

• Connect with local internal and external experts to keep up to date with changes in regulations and supply chain processes.

Responsible for implementing improvements to local processes and driving timely delivery and reliability of supply.

• Coordinate with the TMF documentation team on document preparation, tracking-system updates, and filing, and ensures PMD (or applicable system) inventory accuracy via periodic verifications with the local depot (where available) and site teams, in collaboration with the local team or delegated representative
• May act as IMP cold chain specialist being accountable for the vaccine IMP cold chain end to end management, including: + Accountable for delivery of the cold chain process local training to local sponsor roles and sites and the local management and oversight of vaccines IMP shipment and storage conditions (from manufacturing to destruction at local depot). + Works with study team to prepare sites for working with vaccines IMP (including but not limited to sourcing sites with adequate equipment aligned with SOP requisites and study requirements) + Acts as point of contact for sites in relation to vaccine IMP management being accountable for managing GSK systems and tools to ensure adequate oversight of appropriate supply levels at site, on time reporting and tracking of deviations and appropriate filing of quality decisions.

As needed, coordinates the support of clinical support specialists in cold chain activities.

• Contracts and Other Legal Documents
• Develop and maintain accurate tracking information related to site and supplier contracts, and external costs.

Responsible for collaborating with legal counsel and procurement to maintain Clinical Operations Master templates and service agreements (including site templates), and updating templates as required.

Ensures due diligence, TPO/TPR management of third-party suppliers is complete prior to execution of any contractual agreement.

• Other Clinical Operation Specialist Responsibilities
• Responsible for coordinating and updating information required for institutional reports and external stakeholders.
• Responsible for archiving activities at the end of study in accordance with relevant GSK SOPs, policies and local regulatory requirements.
• 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.
• Leverages AI-enabled tools and digital solutions responsibly to improve efficiency, data quality, and decision-making in clinical trial operations.

Why You?

Working arrangement This role is offered as hybrid working. You will combine remote work with regular time in a UK office and occasional site visits.

• Basic Qualification
• 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 with import/export documentation and cold chain.
• Experience working with clinical supply/depot vendors and couriers.
• Excellent understanding of the external clinical trial environment and UK clinical trials regulations and start-up processes.
• Flexible and responsive to new ideas in a changing environment.
• Preferred Qualification
• 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, Agile Thinking, Business Acumen, Clinical Development, Clinical Research, Clinical Trial Designs, Communication, Creativity, Decision Making, Fostering Collaboration, Good Clinical Practice (GCP), Influencing Without Authority, Pharmaceutical Industry, Project Management, Time Management

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.

GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.

We're uniting science, technology, and talent to get ahead of disease together.

Find out more: Our approach to R&D, Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.

We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.

We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.

We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most.

Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer.

This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles.

If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.

Adjustments@gsk. com where you can also request a call.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels.

However, we have created a Recruitment FAQ guide.

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