1. Act as PAREXEL's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase
2. Conduct, drive and manage country specific feasibility activities, which may include : Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments
3. Configure, distribute, collect, review, and approve (Sr. iCSM) high quality country specific and / or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation
4. Customize, review, and negotiate as required country / site specific Informed Consent Forms (ICF), translations (in accordance with country / regulatory / client requirements), and any amendments
5. Prepare and submit IRB / IEC application in accordance with country / regulatory / client requirements, following up until receipt of final approval
6. Submit all pertinent documentation to the trial master file as per project plans / sponsor / company policy
7. Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner as indicated per project requirements
Job Qualifications :
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.