Country Lead Monitor (CLM) at PRA Health Sciences

Job description

In collaboration with one of our global pharmaceutical client, we now have a Country Lead Monitor (CLM) opening. This is a full time role working from our client's office in Johannesburg, South Africa.

• Country Lead Monitor oversees the conduct of the country level activities to ensure the country meets committed enrollment and timelines and country study budget.
• Country Lead Monitor is accountable and responsible for overall country clinical trial activities, oversees the CRAs and study progress within country from feasibility to study archive. Your involvement begins with managing the country feasibility and site selection team and process to ensure the assigned study is initiated according to timelines. This will involve providing sufficient training to all CRAs assigned to the trial and developing further training plans if needed.
• Country Lead Monitor is managing and tracking the study country budget, oversee study oversight plan to ensure quality and compliance which will include monitoring visits and provide oversight for the CRAs involved in the project.
• Moreover, Country Lead Monitor is responsible for corrective action plans to ensures timely and sufficient resolution of issues that may impact the quality and compliance of the data. On some studies you may also be supporting regulatory and ethics submissions process and also contract negotiations.
• The successful candidate for this role will be able to demonstrate prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
• It is essential that you have prior working knowledge of ICH-GCP guidelines and local and international regulatory requirements. The position also requires awareness and understanding of cultural differences as well as regional operational differences and budget management.
• Fluency in English is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.
• PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.