Study Start Up Specialist

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.

You will be responsible for preparing and submitting regulatory documents to relevant authorities, maintaining site performance metrics, and working closely with Clinical Research Associates (CRAs) and Clinical Trial Managers to ensure milestones are met. Your expertise will help drive the successful initiation of studies, with a primary focus on regulatory submissions, including applications to SAHPRA and substantial amendments to Ethics Committees.

 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).
• Experience with regulatory submissions, particularly in SAHPRA and Ethics Committee applications.
• Excellent attention to detail, organizational skills, and the ability to manage multiple tasks efficiently.