Clinical Studies Leader (CSL) (m/f)

REFERENZNUMMER:

305016/11

IHRE AUFGABEN:

-Provide leadership and direction for all aspects of one or more clinical studies in order to deliver study outcomes within schedule, budget, quality/compliance and performance standards
-Lead and manage one or more global cross-functional Clinical Study Teams (CST) to ensure deliverables are met within the established timelines, budget and quality/compliance standards
-Contribute to CRO selection activities and contract set-up for outsourced studies
-Serve as primary contact with CRO and provide oversight of CRO, ensure communication between CRO, other vendors and CST for the entire study lifecycle
-Assess needs for vendors, identify and select vendors, including negotiation of scope of work and budget with HCO and ensure that related contracts comply with internal SOPs and GCP requirements

IHRE QUALIFIKATIONEN:

-Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote)
-Demonstrated project management experience
-Experience in executing a wide range of clinical trial activities (from initiation to clinical study report)
-In-depth medical/scientific knowledge
-In-depth knowledge of clinical research and drug development
-In-depth knowledge of GCP and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
-Very Good written and oral English language skills

WEITERE QUALIFIKATIONEN:

Clinical project manager