Einführung

Clinical Research Study Leader (m/f/d)

Aufgabenbeschreibung

• Leads the cross-functional Study Management Team (SMT). In the SMT Leader (SMTL) role, the CRSL is 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.
• Prepares and manages 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.
• Identifies 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.
• Assures consistency and standards across a study or studies for all investigational sites and in line with project standards.
• Works with Pharma Development Quality Assurance as appropriate to ensure that studies are conducted to appropriate levels of quality.
• Ensures that all adverse events are documented and that serious adverse events are processed and reported according to current SOPs.
• Reviews study data listings for accuracy, discrepancies and formatting throughout the study and prior to inclusion in regulatory documentation and clinical study reports.
• CRSLII may provide support and mentoring to other CRSLs.
• Displays the Roche leadership commitments and exhibits competencies in key attitudes and behaviours that are critical to complementing what we do as we deliver value to pRED. The key attitudes and behaviours are focused on “How we approach what we do” (composure, organisational agility, self-development and managing vision & purpose), “How we behave” (dealing with ambiguity, creativity, learning on the fly and self-knowledge) and “How we affect others” (informing, understanding others, interpersonal savvy and peer relationships).

Erforderliches Profil

• Minimum 7/8 years 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

Nice to Have:

• Experience with early phases of clinical trials
• NS & Infection & Oncology

Application process