Study Start-up Lead

vor 3 Wochen


Basel, Schweiz CK Group Vollzeit

**Salary**:Up to CHF 69.70 per hour
- **REF Number**:00056323
- **Consultant**:Jim Gleeson
- **Contact**:01438 842973
- **Date Published**:21.11.2023
- **Sector**:Pharmaceutical
- **Location**:Basel, Switzerland
- **Discipline**:Clinical Operations

CK Clinical are recruiting for a Study Start-Up Lead to join a global, blue chip pharmaceutical company, based at their headquarters in Basel. This will be a six month contract starting in mid-January.

RESPONSIBILITIES:
As Study Start-Up Lead you will plan and execute global SSU activities to ensure timely trial document and task completion to enable country HA (Health Authorities) and Ethics Committee submissions and site activation to meet ambitious recruitment plans.

Key duties willinclude:

- Contributing SSU insights to the development of the trial Operational Execution Plan (OEP) and aligning the SSU plan and strategy accordingly as reflected in SSU systems, milestones and dashboards with Study Leader/Clinical Trial Team(CTT)
- Configuring and ensuring proper trial-specific set-up of SSU systems
- Ensuring timely collection global trial level document readiness (including vendor and IMP) and collection into eTMF as necessary for country health authority and Ethics Committee submission and site activation
- Supporting the Vendor Program Manager (VPM) as needed to ensure timely global vendor activation and HA submission documents
- Collaboration with GCS (Global Clinical Supply) to ensure coordination andreadiness of global clinical supply
- Ensuring proper hand-off of activities applicable to the Study Leader and other roles as necessary
- Ensuring the use and date completeness/accuracy of applicable technology platforms during SSU
- Providingoversight and support to country Study Start-up Managers as needed to ensure that study start-up activities are conducted and completed to plan

As Study Start-Up Lead you will require:

- A relevant life science degree
- Proven experience of SSU activities gained in a pharmaceutical company, biotech or CRO
- Proven ability and strong experience in leading multidisciplinary teams in a complex matrix environment

**BENEFITS**:
Up to CHF 69.70 per hour

Apply:
Jim Gleeson

**Client Partner**

T: 01438 870022


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