Global Study Lead – Managed Access Program Experience

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🌐 Bulgaria, Romania, +3 more countries – Remote

🇧🇬 Bulgaria – Remote 🇷🇴 Romania – Remote 🇷🇸 Serbia – Remote 🇭🇺 Hungary – Remote 🇮🇹 Italy – Remote

⏰ Full Time

🟠 Senior

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Provide strategic leadership and overall accountability for operational planning and delivery of assigned studies/programmes from initiation through completion and archiving • Lead and oversee Managed Access Programs across the UK and/or EMEA • Provide leadership and oversight for PACT and/or PTA programmes where applicable • Act as a key member of the Study Leadership Team and represent Clinical Operations in strategic study discussions and decision-making • Own the operational vision and strategy for successful study delivery • Lead global, cross-functional and matrix study teams to achieve programme objectives • Ensure studies/programmes meet agreed timelines, quality and budget expectations • Provide oversight and support to study management colleagues responsible for day-to-day operational delivery • Serve as the primary Clinical Operations escalation point for assigned programmes • Develop operational plans and ensure appropriate feasibility and upfront planning • Identify, assess and mitigate operational risks and issues • Communicate study/programme status, expectations, risks, issues and key decisions to internal and external stakeholders • Provide strategic oversight of operational input into protocols, informed consent forms and other key documentation • Maintain oversight of programme quality, compliance and inspection readiness • Ensure compliance with ICH-GCP, regulatory requirements, SOPs and company standards • Provide strategic oversight of CROs, FSP providers and third-party vendors • Support vendor assessment and selection and ensure ongoing vendor governance and oversight • Maintain accountability for study/programme budgets and contribute to governance and financial review cycles • Build relationships with senior stakeholders and influence decision-making across complex matrix organisations • Drive continuous improvement and identify innovative approaches to operational delivery • Contribute therapeutic-area and operational expertise to delivery across the oncology portfolio

🎯 Requirements

• Significant clinical research and clinical development experience within a pharmaceutical, biotechnology or CRO environment • Proven experience at Global Study Lead, Global Trial Lead, Senior Clinical Trial Manager, Senior Global Study Manager or equivalent level • Previous experience leading or providing significant operational leadership/oversight of Managed Access Programs within the UK and/or EMEA strongly preferred • Extensive experience leading complex global studies or programmes and accountability for operational delivery • Ability to lead high-performing, geographically dispersed and cross-functional matrix teams • Strong understanding of global clinical development, clinical operations and regulatory processes • Experience managing study/programme timelines, budgets, risks and quality • Strong CRO/vendor oversight experience, including performance or quality concern management and escalation • In-depth knowledge of ICH-GCP and relevant global regulatory requirements • Ability to operate autonomously and make complex decisions in fast-paced environments • Strong stakeholder management and ability to influence senior stakeholders • Excellent leadership, communication, negotiation and conflict-resolution skills • Strong project and programme management capabilities • MAP leadership experience within the UK and/or EMEA highly desirable • PACT experience highly desirable • PTA programme experience highly desirable • Oncology study or programme experience advantageous • Experience within a global pharmaceutical FSP or embedded delivery model desirable • Experience leading complex, innovative or non-traditional clinical programme models desirable • Experience working with investigators, external experts, regulatory authorities, CROs and third-party vendors desirable • Bachelor's degree in Life Sciences, Health Sciences or a related scientific discipline, or equivalent relevant experience

🏖️ Benefits

• Reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment • Equal Opportunity Employer