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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 client standards.
Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs.
- Initiate and coordinate activities and essential documents management during start up towards the compilation of a high quality Investigator
- Initiation Package (IIP) leading to approval for site initiation
- Provide support to resolve issues or concerns and timely escalation of site issues where applicable
- Prepare, validate and submit regulatory documents such as completedIIP, Institutional Review Board (IRB) approval forms, FDA 1572 / Attestation Form, for internal regulatory approval within required timelines
- Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
- Support the compilation of the Central Investigator Review Board package and submissions to approval of the study and other committees as per country requirements
- Coordinate the timely communication, documentation and responses between client and central ethics committee to bring clinical study to approval
- Support investigators sites with local IRB workflow from preparation, submission through approval
- Assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures
Knowledge and Experience :
- Experience working in the pharmaceutical industry / or CRO in study site activation preferred
- Knowledge of clinical trial methodologies, ICH / GCP, FDA and Global and local country regulations
- Good technical skills and ability to learn and use multiple systems
Education :
- Bachelor of Science or Bachelor of Arts or equivalent
- Education in life sciences discipline is preferred
- Minimum 2 years relevant experience in clinical site management
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