• Lead the cross-functional Study Management Team (SMT).
• In the SMT Leader (SMTL) role, as the CRSL you are responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting.
• The SMTL is accountable for the delivery of the clinical studies within the agreed timelines, budget and quality.
• Prepare and manage the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking.
• Identify key milestones and tracks critical study activities, issues and strategic priorities. Provides regular updates as appropriate, to key stakeholders.
• Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site selection, initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines.
• For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study lifecycle.
• Assure consistency and standards across a study or studies for all investigational sites and in line with project standards.
• Profound experience in study management with extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies
• Minimum Bachelor (preference on Master) in Life Sciences
• Experience with global study management
• Experience in pharma (preferred) or CRO
• Effective leadership skills, able to lead cross-functional teams across multiple time zones
• Experience working in matrix environment and flat hierarchical team setting
• Interesting tasks in a multinational environment
• Good infrastructure
• Dynamic and innovative market environment
Projektdauer: 6 MM+
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