Einführung

Clinical Operations Lead (Legacy BOPM)

Aufgabenbeschreibung

• Provide BIOMARKER OPERATIONAL EXCELLENCE by planning, coordinating, and overseeing all operational activities for the lifecycle of biomarker and companion diagnostic samples and data, for clinical studies.
• Collaborate with cross-functional STUDY and BIOMARKER TEAMS to execute biomarker operational strategies.
• Lead identification, selection and oversight of BIOMARKER VENDORS, ensuring quality delivery and performance.
• Develop and oversee biomarker analysis TIMELINES, BUDGET, RISK, COMPLIANCE and QUALITY, ensuring study adherence to ICH/GCP and SOPs.
• LEAD AND INFLUENCE by establishing yourself as a leader within the team, inspiring others to perform at their best and learn from biomarker operations best practices. You will be shaping our capabilities and evolving your role over time.
• DESIRABLE EXPERIENCES: Background in life sciences. Laboratory experience in a clinical / biological / diagnostic setting. Project management. Experience in a pharmaceutical/biotechnology R&D environment.

Erforderliches Profil

• Min Bachelor/Master in Life Sciences (biology and/or chemistry) (PhD & Post Docs are considered) 
• Minimum 3 years of experience in a clinical research setting, including at least 1 year working in pharma clinical operations
• Strong experience with vendor and project management
• Possess strong knowledge of drug development process and respective regulations, including ICH and GCP guidelines 
• Have a clinical or laboratory experience with evidence of involvement in the processing and/or analysis of biological sample
• Experience working in a global and matrix environment
• Excellent collaboration, communication and presentation skills

Application process