Clinical Operations Specialist

2 mesi fa

, Italia GSK Tempo pieno

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

Job title: Clinical Operations Specialist

Location : Verona - modalità ibrida

Employment type: Permanent, full time

Closing date for applications: 22 luglio 2026 COB

Position Summary

Leads the co-ordination and delivery of specialized operational activities according to ICH GCP, international and local regulations, and relevant GSK written standards. The Clinical Operations Specialist plays a pivotal role as a member of the local clinical study team and is responsible for contributing to the planning, execution, and delivery of the Clinical trial in the country.

Responsibilities

Clinical Supplies and Logistics

  • 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.
  • Responsible for oversight of vendor(s) managing local clinical supplies storage and supply distribution.
  • Maintain expert knowledge of requirements for importation and distribution of supplies according to local regulations and manufacturer requirements
  • 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

Study Feasibility

  • Support executing Confidentiality Agreements, Conflict of Interest forms and collecting Data Privacy Notices.
  • Actively works with stakeholders to simplify/optimize processes as it relates to their area of expertise.

Budget Development and Negotiation

  • 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.
  • Responsible for ensuring TMF completeness for all budget and contracting activities

Financial analysis, Forecasting and Payments

  • Responsible for ensuring timely and accurate payments to investigator sites/vendors as per the agreed contract. Will set-up, input and manage the payment schedule within dedicated systems.

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.
  • Leverages AI-enabled tools and digital solutions responsibly to improve efficiency, data quality, and decision-making in clinical trial operations

Why you?

Basic Qualifications & Skills

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor’s degree in Finance, Law and/or Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or at least 2 years of experience in clinical operations or similar positions in the pharmaceutical industry.
  • Solid knowledge of ICH-GCP, local regulations, and regulatory processes.
  • Excellent communication skills in English and Italian, both written and spoken.
  • Solid digital skills, including confident use of modern collaboration tools and digital platforms (e.g. AI tools).

Preferred Qualifications & Skills

If you have the following characteristics, it would be a plus:

  • St