Country Study Manager (Local Delivery Lead)

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Acts as the primary operational link between central and local study teams, medical, and regulatory staff. Facilitates alignment on feasibility, site selection, and local requirements. Ensuring that study systems (e.g., TMF) are complete and accurate, and progress is effectively reported to stakeholders. Where applicable, act in an above-country role, e.g., LDL SPOC, Regional LDL, Global Program Lead (GPL) and participates in global initiatives and cross-country activities, serving as the global/regional GMASE interface for alignment, escalation and harmonized delivery of multi-country national study objectives. •

Oversees that critical study timelines, recruitment targets, patient recruitment cycle times, data integrity, and audit quality are forecasted, monitored, and achieved. Provides troubleshooting and problem resolution support, identifies risks, and escalates issues as needed to maintain productive, efficient study delivery. •

Ensures all regulatory requirements are met by preparing and coordinating submissions of Clinical Study Applications and local Informed Consent Forms to Regulatory Authorities (RA) and Ethics Committees (ECs). Maintains ongoing communication and assists with audits and inspections of local clinical operations and study sites. •

Estimates, tracks, and delivers against local study budgets. Advises on contract development with sites, CROs, and vendors, participates in negotiations, reviews and approves monitoring visit reports, and verifies that monitoring activities are completed according to plan. Supports financial and contractual compliance throughout the study lifecycle. •

Acquires and maintains knowledge related to study compounds, protocols, disease area pathology, local treatment guidelines, and healthcare system requirements. Continuously develops skills in GCP, SOPs, monitoring, site and project management, and shares best practices. Leverages AI-enabled tools and digital solutions responsibly to improve efficiency, data quality, and decision-making in clinical trial operations.

This role offers a hybrid working model, with a mix of on-site and remote work. Fully remote or home-working arrangements are not available for this role.

Please take a copy of the Job Description, as this will not be available post closure of the advert.   When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

Clinical Development, Clinical Project Management, Clinical Research, Clinical Research Organizations (CRO) Management, Clinical Research Trials, Clinical Trial Management, Clinical Trial Process, Clinical Trials, Drug Development Research, Effective Communication, Pharmaceutical Regulatory Compliance, Quality Assurance (QA), Regulatory Oversight, Relationship Management, Study Management

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. Click the link where you will find answers to multiple questions we receive

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