The International Clinical Trial Manager (ICTM)
- Is a global role based in Basel
- Is a member of the Clinical Operations Team
- Works closely together with the International Clinical Program Leader (ICPL) and International Clinical Trial Associate
Provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Start-up, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations
Provides direction and leadership to one or more clinical operations teams (depending on competency level ICTM may not have leadership responsibilities)
- Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
- Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
- Creates team culture and promotes team spirit.
- Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external providers and collaborative partners.
- In collaboration with functional management, coaches, supports, and provides study specific direction to Study Management team members.
- Oversees the development and maintenance of study specific manuals created by the ICTA.
- Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment.
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
- Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments
- Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
- Good knowledge of ICH GCP
- knowledge Clinical Trial management within the therapeutic area is desirable
- Proficient computer skills across multiple applications
- Fluency in written and spoken English
- High ethical standards
- Ability to demonstrate our customer Values and Leadership Commitments
- Pharma Core Competencies
- Project Management
- Collaboration and Teamwork
- Personal Organization
- Cost and financial awarenes
- Decision Making