Study Start-up Lead

vor 2 Wochen

Basel, Schweiz CTC Resourcing Solutions Vollzeit

**The Life Science Career Network**

Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.

We are currently looking for a:
**Study Start-Up Lead**

for a 6 month-contract based in** Basel, Switzerland.**

**Main Responsibilities**:

- Planning and executing global study start-up activities to ensure timely trial document and task completion to enable country Health Authorities and Ethics Committee submissions and site activation to meet recruitment plans;
- Contributing to study start-up insights to the development of the trial Operational Execution Plan;
- Configuring and ensuring proper trial-specific set-up of study start-up systems;
- Implementing global aspects of protocol and Operational Execution Plan amendments;
- Ensuring timely collection global trial level document readiness and collection into eTMF as necessary for country health authority and Ethics Committee submission and site activation;
- Supporting the Vendor Program Manager as needed;
- Ensuring Protocol and Informed Consent Form global trial template is ready for country usage as necessary including translations;
- Providing proactive oversight and risk management to achieve start-up timelines and quality execution;
- Providing oversight and support to country Study Start-up Managers.

**Qualifications and Experience**:

- **Relevant working/residency permit or Swiss/EU-Citizenship required;**:

- Proven ability and strong experience in leading multidisciplinary teams in a complex matrix environment (including remote or virtual team environments);
- High learning agility championing new technology platforms;
- Strong problem solving, negotiation, deadline driven and conflict resolution skills;
- Experience at handling high quality, timely study start-up deliverables, documentation and data in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP (Standard Operation Procedure) requirements.

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