Study Start-Up Specialist/Site Activation Partner - FSP

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 Partneris 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

Originally posted on Himalayas