Job Description

The Site Activation Partner II (SAP II) 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 Client standards. Responsibility span within a country or multi-country depending on the geographical region and business needs.

Organizational Relationships:

Reports to the ExecuPharm (EP) assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure
Partners with Global Site and Study Operations (GSSO), Clinical Development and Operations (CD&O), Regulatory Affairs, Pharmaceutical Sciences, Medical Quality Assurance, Legal, and Drug Safety Unit

Qualifications

Education:

School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor's degree in life sciences preferred

Relevant experience in Clinical Trials environment and clinical site activation.

Experience working in the pharmaceutical industry/or CRO is an asset

Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations

Must be fluent in Local language and in English.

For individuals based in Canada: Bilingualism (French, English) is an asset

Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

Good technical skills and ability to learn and use multiple systems

Experience working in a global environment

Experience in working in more than 1 country is an asset

Demonstrated knowledge and understanding of key operational elements of a clinical trial and

processes (e.g., study start-up, conduct, close-out activities, reporting, etc.) and ability to gain

command of these processes

Understand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements. Attention to detail evident in a disciplined approach

Proven ability to work independently and also as a team member

Ability to organize tasks, time and priorities, ability to multi-task

Understand basic medical terminology, GCP requirements and proficient in computer

operations.

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.