Site Activation Partner launching clinical trials for ICON’s sponsor - dedicated research programs. Coordinating regulatory submissions, approvals, and study - startup documentation.
About the role
- Site Activation Partner at Parexel leading operational activities for clinical trials and site compliance. Collaborating with regulatory groups and managing investigator site issues.
Responsibilities
- 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
Requirements
- 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
Benefits
- Health insurance
- Professional development opportunities
Job title
Job type
Experience level
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Not specified
Degree requirement
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