Clinical Trials Project Leader - Pharmaceuticals at Kelly

We're seeking a Clinical Trial Project Leader (Pharmaceuticals) – Midrand to be responsible for allocated clinical trials/studies within the cluster, ensuring compliance with the companies quality standards and processes, regulations in force, the forecasted

Responsibilities 

• Overall responsible and accountable for allocated clinical trials within the Clinical Study Unit.
•  All study related activities at various stages of a clinical study – start up, recruitment, maintenance,close out and archiving.
• Study activities performed according to Good Clinical Practice, regulations in force and company standards and processes.
• Supports the management team in driving the Clinical Study Unit       
• Primary contact with identified key stakeholders - Ensures appropriate communication and support with these stakeholders.
• Selection of clinical trial sites.
• Submissions to Ethics Committees / IRBs
• Training of sponsor and clinical trial personnel on study related processes and requirements.
• Contract negotiation and agreement with Clinical Trial sites.
• Maintaining clinical study documentation in an audit ready state.
• Compliance with requirements to all study related databases.
• High quality standards of study data collection and prompt data query resolution.
• Adequate provisioning of study materials and devices.
• Oversee monitoring activities through regular contacts with local monitoring team, local teammeetings, review of monitoring visit reports and adherence to the monitoing plan.
• Preparation and prompt responses to audit/inspection reports and implementation of recommendations.

Qualifications and Experience

• University degree in Health Sciences or equivalent
• Clinical Research experience essential, minimum 5 years
• Knowledge of GCP/ICH phase I-IV clinical trials
• Computer skills must include working knowledge of Excel, PowerPoint,
• Word and Outlook
• Project and people management skills
• Organizational, analytical and planning abilities
• Fluent in English
• Literate in French will be an advantage