The Principal Clinical Trial Lead (PCTL)…
• is responsible for the strategic and tactical operational delivery and execution of R&D spon-sored programs for all corporate sponsored programs for Phase I – Phase IV.
• is responsible and accountable for planning, coordinating, overseeing, and conducting com-plex global clinical trials in one or more therapeutic areas
• contributes strategic, value-added perspectives or advisory services that are important to de-cision, collaborating in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services
• is accountable to drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations.
• leads multiple cross-functional teams and drives oversight of CRO’s and vendor management according to partnership model
• has in-depth business knowledge and strategic understanding of how cross-functional teams jointly achieve objectives and goals of trial team, utilizing knowledge of the organization, pro-cesses, customers and key business drivers to increase effectiveness
• has significant impact on a range of important customer, operational, project or service activ-ities within own team and other related teams that affect team performance and the way people work.
• 8 – 10 years in clinical research in CRO, Pharmaceutical or Biotechnology Industry
• At least 5 years of expertise in clinical trial management
• Experience in all phases (I – III/IV) of clinical studies
• Experience in all stages of trial – from Start-up to Close Out > 5 yrs.
• Has lead one or more global clinical trials
• Pharma or CRO experience > 5 yrs.
• Study budget management > 5 yrs.
• TA experience in Oncology or Immunology > 5 yrs.
• global study management Position requires both domestic and international travel up to 30 days
• English business fluent
Location: Darmstadt & Remote
Project start: June 2018
Duration: 200 days until 31.03.2019
Availability: 80% onsite support, 20% remote