Global Study Lead - FSP - EMEA - Managed Access Program Experience

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Thermo Services (Hungary) Kft.
Munkavégzés helye

Budapest
Profession Prémium

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Munkaidő, foglalkoztatás jellege
- Alkalmazotti jogviszony
- Általános munkarend
Elvárások
- Angol középfok
- 5-10 év tapasztalat
- Főiskola

Állás elmentve

A hirdetést eltávolítottuk a mentett állásai közül.

Responsibilities

Strategic leadership and overall accountability for operational planning and delivery of assigned studies and programmes
Leadership and oversight of Managed Access Programs across the UK and/or EMEA
Leadership and oversight for programmes involving Post-Analysis Continuation of Treatment and Post-Trial Access
Membership and representation in the Study Leadership Team for strategic study discussions and decision-making
Ownership of operational vision and strategy for successful study delivery
Strategic leadership of global, cross-functional and matrix study teams
Ensuring studies and programmes are delivered to agreed time, quality and budget expectations
Oversight and support to study management colleagues for day-to-day operational delivery
Primary Clinical Operations escalation point for assigned programmes
Development of robust operational plans including feasibility and upfront planning
Proactive identification, assessment and mitigation of operational risks and issues
Effective communication of study and programme status, expectations, risks, issues and key decisions to stakeholders
Strategic oversight of operational input into protocols, informed consent forms and other key study documentation
Maintenance of programme quality, compliance and inspection readiness
Compliance with ICH-GCP requirements, regulatory requirements, SOPs and company standards
Strategic oversight of CROs, FSP providers and third-party vendors including escalation of performance or deliverables risks
Support for vendor assessment, selection and ongoing governance
Accountability for study and programme budgets and contribution to governance and financial review cycles
Building effective relationships with senior stakeholders and influencing decision-making
Driving continuous improvement and identifying innovative approaches to operational delivery
Contribution of therapeutic area and operational expertise to support oncology portfolio delivery

Requirements

Significant clinical research and clinical development experience within pharmaceutical, biotechnology or CRO environment
Experience operating at Global Study Lead, Global Trial Lead, Senior Clinical Trial Manager, Senior Global Study Manager or equivalent level
Experience leading or providing significant operational leadership or oversight of Managed Access Programs within the UK and/or EMEA
Extensive experience leading complex global studies or programmes with 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 and programme timelines, budgets, risks and quality
Strong CRO and vendor oversight experience including management and escalation of performance or quality concerns
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 skills with ability to influence senior stakeholders
Excellent leadership, communication, negotiation and conflict-resolution skills
Strong project and programme management capabilities
Bachelor's degree in Life Sciences, Health Sciences or related scientific discipline or equivalent relevant experience

Nice-to-have

Experience with Post-Analysis Continuation of Treatment
Experience with Post-Trial Access programmes
Previous experience supporting oncology studies or programmes
Experience working within a global pharmaceutical FSP or embedded delivery model
Experience leading complex, innovative or non-traditional clinical programme models
Experience working with investigators, external experts, regulatory authorities, CROs and third-party vendors

Company info

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.