Study Start Up Specialist

3 days ago

Johannesburg, South Africa ICON Full time

We are currently seeking a **Study Start Up Specialist** to join our diverse and dynamic team. As a **Study Start Up Specialist**, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will play a pivotal role in launching clinical trials, ensuring all start-up activities are managed efficiently and in compliance with international standards and local regulations.

**Other **Responsibilities**

***
- Lead and coordinate study start-up activities, including feasibility assessments, regulatory submissions, and site activation.
- Oversee the collection, review, and tracking of essential documents, ensuring accurate and timely submissions to regulatory authorities and ethics committees.
- Collaborate closely with CRAs and the CTM to meet study start-up timelines and resolve any site-related issues promptly.
- Ensure timely updates in Clinical Trial Management Systems (CTMS) and eTMF in compliance with ICH-GCP, SOPs, and local regulatory requirements.
- Participate actively in study team meetings, providing key updates on study progress and site performance.
- Support the Clinical Trial Manager in quality control checks to ensure that all essential documents are in place before site activation.
- Monitor and report on key study milestones, sharing insights on potential site challenges or market intelligence that could impact the study.
- A **Bachelor’s degree** in Life Sciences or a related field.
- At least **3 years of experience** in Study Start-Up.
- Strong understanding of **ICH-GCP** guidelines and local regulations, with basic knowledge of **Good Manufacturing Practice (GMP)/Good Distribution Practice (GDP)**.
- Excellent attention to detail, organizational skills, and the ability to manage multiple tasks efficiently.

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