Global Studies Manager
Kelly Scientific Resources (KSR), a division of Kelly Services, is the worldwide leading provider of scientific personnel. Our team in Basel (Switzerland) consists of experts with a solid background in chemistry, pharmacy or biotechnology, as well as several years of consultancy experience.
For our customer, an internationally leading pharmaceutical company with headquarters in Basel (Switzerland), we are looking for an experienced
Global Studies/Study Manager
The Global Studies Manager (GSM) provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.
- Provides direction and leadershipto one or more clinical operations teams
- Develops operational plans including site monitoringstrategies, risk mitigation strategies, trial budgets,site selection, and clinical supplies management.
- Builds effective and efficient high performing operationsteams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
- Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams,external CRO (for outsourced teams) and co-development partner study teams.
- In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members.
- Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
- Develops and manages clinical study budgets(including HQ budget) and contributes to staffing/resourcing plans. Communicates variances in the budget and action plan for resolution to the GSL.
- Establishes study milestones and ensures accurate trackingand reporting of study metrics.
- Oversees forecasting of clinical/non-clinical supplies
- Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings.
- Proactively manages actual study level recruitment versus planned patient recruitment status
- Primary contact with affiliates to maintain oversight of performance
- Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs.
- Provides the day-to-day operational management of CROs and vendorsto ensure delivery against contracted scope of work
- Maintains oversight and ensures consistency of the operational aspects across studies within a project.
- 3-5 years in a similar role with global operational leadership project management experience
- Experienced in global budget management
- Knowledge of vendor management
- Good interpersonaland communication skills
Duration: 12 month with chance of prolongation
Work location: Basel
Please apply online on www.kellyservices.ch, or send your full application (CV in English, copies of your diploma and reference letters) to Danielle Joseph Danielle.joseph(at)kellyservices.ch