The Clinical Project Leader is responsible and accountable for clinical project planning, organization, implementation, tracking and evaluation of global clinical trials (phase I – IV) according to ICH and GCP standards, other applicable regulations and internal SOPs. This includes also the coordination, cooperation and supervision of trial-related activities within Allergopharma and clinical CROs and with further service providers in the field of clinical trials. The Clinical Project Leader is accountable to drive and monitor protocol related activities throughout the lifecycle of the study ensuring targets are met according to timelines, budget and quality expectations. The Clinical Project Leader works in cross-functional teams and drives oversight of CRO’s and vendor management, has in-depth knowledge of clinical operations and strategic understanding and experience of how cross-functional teams jointly achieve objective, utilizing knowledge of the organization, processes, customers and key business drivers to increase effectiveness. The Clinical Project Leader prepares status reports and is responsible for all activities related to clinical trial management, from planning through organization to successful completion. This includes: Preparation of study outlines, study protocols, investigator information meetings and clinical trial reports, CRFs, Ensuring the correct creation and archiving the Trial Master File (TMF) and Preparation of study-relevant information for authorities and ethics committees and investigator meetings.
- pharma or biotechnology industry > 5 yrs.
- Clincal studies – project mgmt. > 5 yrs.
Projektbeginn: Mai 2019
Projektlaufzeit: 128 Tage bis 31.12.2019