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Global Studies Manager (Clinical Trial Manager) (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Affiliate
Projektbeschreibung
- Provide direction and leadership to one or more clinical operations teams
- Contribute to the development and management of the study timelines, resources, budget, risk and quality plans
- Provide clinical operations expertise to ensure operational feasibility and delivery
- Oversee forecasting of clinical/non-clinical supplies
- Deliver the operational elements of the study plan
- Provide the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
- Identify areas of best practice and process improvements
- Ensure study adherence to ICH/GCP and SOPs
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans
- Good knowledge of ICH GCP
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
- Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitment
- Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
- Fluent English
- Experience in CNS an advantage
Weitere Qualifikationen: Clinical trial manager
- Contribute to the development and management of the study timelines, resources, budget, risk and quality plans
- Provide clinical operations expertise to ensure operational feasibility and delivery
- Oversee forecasting of clinical/non-clinical supplies
- Deliver the operational elements of the study plan
- Provide the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
- Identify areas of best practice and process improvements
- Ensure study adherence to ICH/GCP and SOPs
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans
- Good knowledge of ICH GCP
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
- Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitment
- Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
- Fluent English
- Experience in CNS an advantage
Weitere Qualifikationen: Clinical trial manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb