Description
We are looking for a
Global Studies Lead (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Provide direction and leadership to one or more global Study Management Teams (SMTs) to ensure delivery of all cross functional activities in line with the clinical development plan
- Create and manage study timelines, budget, resource, risk and quality plans
- Provide direction and oversight of outsourced activities to ensure CRO and vendor delivery against contracted scope of work
- Identify and contribute to areas of best practice and process improvements
- Provide study specific mentoring to GSMs and Global Studies Associates (GSAs) and partners with functional managers to contribute to GSMs and GSAs development needs
- Ensure study adherence to ICH/GCP and SOPs
Your qualifications
- Strong leadership and motivational skills developed through leading successful global multi-functional matrix
- Experienced project manager, having led the development and implementation of plans including but not limited to study milestone and risk management plans
- Experience creating and managing complex study budgets
- Proven experience in all aspects of clinical studies including vendor/CRO management, leading/working as part of a HQ development team and coordinating study level activities to deliver data for filing or publication purposes
- Clear understanding and experience applying ICH/GCP
- Strong knowledge of and experience in the drug development process and the pharmaceutical industry
- Excellent written and verbal communications skills
Skills:
- Clinical project manager