For our Swiss customer located in Basel we are currently looking for (m/f) a Global Studies/Study Manager (GSM ) PHARMA
- Type of placement: 12 months, external contract with possible long term extension
- Company: major Pharma company in Basel area
- Salary: level 2-3, please ask us for the exact rate range
(monthly gross salary levels in CHF, level1= 5-10k , level2=10-15k, level3= >15k) -PHARMA
The positions are open in the Oncology Team
Duration: 1 year
Notice period: 2 month
- Provides the operational expertise and leadership to one or more cross-functional global Study Management Teams (SMTs)
- Ensures the timely and efficient delivery of all operational aspects of one or more studies through all phases (phase 1b-IV) and stages (start-up, conduct and close-down), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.
Main Responsibilities and Accountabilities
- Provides direction and leadership to one or more global Study Management Teams (SMTs)
- Contributes to the development and management of the study timelines, budget, risk and quality plans
- Provides clinical operations expertise to ensure operational feasibility and delivery
- Oversees forecasting of clinical/non-clinical supplies
- Delivers the operational elements of the study plan
- Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
- Identifies areas of best practice and process improvements
- Ensures study adherence to ICH/GCP and SOPs
- Life sciences degree or nursing equivalent.
- 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 and budgets.
- 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 commitments.
- 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.
- Strong attention to detail
- Proficient computer skills
- Technical and Business ExpertiseTeamwork and Collaboration
- nAchieving Results
- Mobile: Some travel may be required