COMPLETE Director Study Start-up Delivery - EMEA, CH, Kanton Bern, Bern, CSL Behring

Reporting to the Sr Director Clinical Development Operations, Global Feasibility and Start-up Support, you will provide start-up execution options to be evaluated by the Study Execution Teams (SET).

You will lead important study startup activities for Clinical Development (CDO) including:

• Delivering detailed program and study start-up and site activation execution plans to support SET leaders.
• Determining appropriate base and surge resource models for functions supporting startup-activities; enable line of sight with partner functions and CROs regarding the timeline for surges in the CSL clinical portfolio to ensure adequate resources are in place.
• Identify gaps in the intelligence and problem solve to fill these gaps over time through novel methods such as patient-based resource, EMR partnerships to identify participants.

 Role and Responsibilities:

• Accountable and responsible for ensuring that start-up systems and standards are set-up and implemented consistently across product portfolios.
• Accountable and responsible for defining and developing effective study start-up processes with the delivery of site activation as per the integrated feasibility and operations strategy plan.
• Accountable and responsible to build a knowledge platform that can capture intelligence for current and future use and that can help to clarify complex data into accurate and clear messages to facilitate informed business decisions.
• Responsible for leading and contributing to the data driven methodology for ensuring that the start-up and site activation strategy is ed in the incorporated in the integrated feasibility and operational strategy plan.
• Responsible for line management, mentoring and developing the study start-up team as per CSL values and lead by example continuous improvement.
• Responsible for building partnership with the clinical development team (CDT), clinical development operations (CDO) and study execution teams (SET) to optimize study start-up efficiency.
• Driving study start-up initiatives to implement innovative solutions for quality-by-design study start-up and execution accuracy.
• Maintaining a working knowledge of current and new industry practices/trends and global regulations governing the clinical trial business.

Background education and past experiences:

• Master in clinical research and process management with a strong background in clinical Operations
• Past experiences in pilot plants/industrial start up in pharmaceutical /Clinical Research Organization is key to succeed in this position.
• Extensive experience (>10years) in clinical operations project management, with a focus on study start-up activities and site activation.
• Extensive expertise in study startup tools and systems, leading and driving key principles of start-up strategies is a must.
• Strong ability to manage a team of experts.
• Extensive expertise in clinical trial regulatory environment in multiple regions (EU, NA, APAC, LATAM) to contribute and leverage knowledge and insights to interpret feasibility insights and propose a site activation process in function of the operational readiness strategy is a must.
• Ability to clarify complex data analyses into accurate and clear messages to facilitate informed business decision.
• Experience in line management and working in a global matrix model.

Our Benefits

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About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

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As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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