[Hiring] Site Activation Partner @Parexel

Role Description

The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and sponsor standards.

• Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation.
• Provide support to resolve issues or concerns and timely escalation of Site issues where applicable.
• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
• Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required.
• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines.
• Identify and resolve investigator site issues.

Qualifications

• School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred.
• Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation.
• Experience working in the pharmaceutical industry/or CRO is an asset.
• Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations.
• Must be fluent in Local language and in English. Multi-language capability is an asset.