Offer summary

Qualifications:

School diploma or equivalent; a bachelor's degree in life sciences is preferred., At least 2 years of relevant experience in clinical trials and site activation., Knowledge of clinical trial methodologies, ICH/GCP, FDA, and global regulations., Fluency in the local language and English; multilingual skills are a plus..

Key responsibilities:

Lead or support operational activities from start-up to close-out for assigned studies and sites.

Coordinate activities and manage documents for investigator site initiation.

Support issue resolution and escalate site issues as needed.

Ensure timely site activation and maintain accurate clinical trial systems.

Job description

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