Site Activation Lead – Clinical Trials Operations

Parexel; United States; Remote; USD 65,000 - 90,000; Full time

Job summary

Parexel is seeking a Site Activation Partner to lead or support operational activities from study start-up to close-out. You will ensure site activation timelines are met, maintain essential documents, and collaborate with regulatory teams to navigate in-country approvals.

The role requires 2+ years in clinical trials, knowledge of ICH/GCP, and fluent English and local language skills. Pharmaceutical or CRO experience is a plus.

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.

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

Skills

Clinical Trials

Site Activation

GCP/ICH

Regulatory Knowledge

English Proficiency

Education

BS/BA Life Sciences

Tools

Clinical trial systems

Job description

Parexel is seeking a Site Activation Partner to lead or support operational activities from study start-up to close-out. You will ensure site activation timelines are met, maintain essential documents, and collaborate with regulatory teams to navigate in-country approvals.

The role requires 2+ years in clinical trials, knowledge of ICH/GCP, and fluent English and local language skills. Pharmaceutical or CRO experience is a plus.