Site Activation Partner - site start up- FSP
Required skills
- Clinical Trials
- site activation
- ICH/GCP
- FDA regulations
- Global regulations
- Local country regulations
- Clinical trial systems
- Essential documents management
- Local language
- English
Nice to have
- Pharmaceutical industry
- CRO
- Multi-language capability
Role summary
Parexel is seeking a Site Activation Partner I to lead or support operational activities for clinical trials from start-up to close-out. This role ensures compliance with study timelines and regulations by managing essential documents, coordinating with regulatory groups, updating clinical trial systems, and resolving site issues. The position requires a minimum of 2 years of relevant experience in clinical trials and site activation, with a preference for a BS/BA degree in life sciences. Knowledge of clinical trial methodologies, ICH/GCP, and relevant regulations is essential. Fluency in the local language and English is mandatory, with multi-language capability being an asset.
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
The Site Activation Partner I 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. Other duties to include but not limited to:
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
Experience required for this role:
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
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