Clinical Study Lead

Overview

Die Position

Your Responsibilities

• Ensures study adherence to appropriate guidelines (ICH GCP/GVP/GPP), relevant regulations and Roche procedural documents. Ensures study inspection readiness at all times. Ensures the completion and finalization of any corrective and preventive action plans resulting from site audits and inspections
• Provides operational input and insights into the development of study protocols, Clinical Study Reports, informed consent form and protocol feasibility questionnaires
• Promotes operational excellence. Oversees the delivery and maintenance of essential study plans and systems (e.g. site& country selection and monitoring plan; study tracking systems, clinical supply; vendor oversight plan; RBQM or equivalent risk management activities). Ensures accurate tracking and reporting of study metrics
• Chairs Study Management Team meetings and organizes the investigator meetings and study kick-off meetings
• Establishes and maintains study budgets and approves invoices, identifies and communicates any issues/variances with study budgets and action plans for resolution
• Accountable for all vendor related operational study deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Leads vendor selections by reviewing proposals and providing recommendations, reviews and negotiates clinical work orders. Maintains oversight of vendor performance, issues, and their resolution and identifies systematic issues and coordinates any corrective action. Ensures vendors receive appropriate training.
• Ensures proper handling of all study close out activities including but not limited to the site close out, final drug accountability, final safety reconciliation and Inspection readiness of Trial Master File documentation.
• Who you are
• Strong leadership skills developed through leading successful multi-functional matrix study teams through all stages of clinical studies.
• Proven strategic capabilities, organizational awareness and proactive planning with embedded contingencies and risk management mindset.
• Clear understanding and experience applying ICH/GCP and/or GVP/GPPs and applicable regulations including awareness of quality requirements.
• Well-developed written and verbal communication skills demonstrated by an ability to present clear instructions/directions, to motivate your team, negotiate with peers and partners and influence cross functionally.
• Excellent problem solving, negotiation and conflict resolution skills
• Borderless Collaboration: working closely with other countries/communities/teams, embracing the loop of ‘sharing and learning together’ to co-create Solutions
• Budget Management- cost effective management with limited unforeseen cost overruns.
• Wer wir sind
• Eine gesündere Zukunft treibt uns zur Innovation an.
• Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen.
• Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt.
• Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
• Gemeinsam können wir eine gesündere Zukunft gestalten.
• Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.