R0000046018 Site Activation Partner (6-Month Temporary) - France (Home-based) - 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.

About Parexel

Parexel is a leading global clinical development partner delivering insights driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.

About the Role

We are seeking a Site Activation Partner to join our team in a temporary capacity (initially for 6 months). As a Site Activation Partner, you will play a critical role in advancing clinical research by leading and supporting site activation and study operational activities from start-up through close-out. This position helps ensure investigator sites are prepared, compliant, and activated on schedule, enabling the successful delivery of clinical trials that bring new treatments to patients.

You will collaborate closely with investigator sites, study teams, regulatory stakeholders, and cross functional partners to manage essential documentation, support regulatory submissions, maintain clinical trial systems, and drive operational excellence throughout the study lifecycle. This role offers the opportunity to build deep expertise in site activation, regulatory processes, and clinical trial operations while contributing directly to the success of global research programs.

You will join a fast paced, growth-oriented environment focused on delivering high quality site activation, regulatory compliance, and study execution. With diverse teams and continuous learning opportunities, the Site Activation Partner can explore career growth and expand expertise across clinical research operations.

Key Responsibilities

• Lead and coordinate site activation activities and essential document management to support timely site initiation and study start-up.

• Work directly with investigator sites to assess readiness, review site information, and ensure completion of Investigator Initiation Package requirements.

• Prepare, validate, and submit regulatory documentation, including Investigator Initiation Packages, IRB approvals, and FDA 1572 or Attestation Forms within required timelines.

• Manage investigator site registration and maintenance within client systems, registries, and clinical trial platforms while ensuring inspection readiness.

• Collaborate with study teams and supporting functions to achieve timely site activation and operational milestones.

• Support ethics committee and IRB submissions, communications, approvals, and ongoing maintenance activities as required by local regulations.

• Coordinate document translation activities with approved vendors when applicable.

• Manage essential document collection, maintenance, filing, archiving, and trial master file contributions in accordance with procedures and quality standards.

• Maintain accurate clinical trial systems and tracking tools used to monitor site compliance, documentation status, and study performance.

• Support investigator sites and study teams in preparation for audits and inspections and assist with responses when required.

• Identify, resolve, and escalate site related issues as appropriate while supporting corrective and preventive actions.

• Contribute to process improvement initiatives, system expertise, knowledge sharing, and mentoring activities as assigned.

Candidate Profile

You will thrive in this role if you bring:

• Strong organizational, documentation management, and stakeholder engagement skills

• Experience working in clinical research, site activation, or a regulated environment

• The ability to collaborate across global teams and communicate effectively with investigator sites and study stakeholders

• A quality focused mindset with strong attention to detail and commitment to compliance

• Comfort working with CTMS, eTMF, eISF, document exchange portals, Shared Investigator Platform, and related clinical systems

Required Qualifications

• Bachelor's degree

• Minimum 2 years' relevant experience in clinical site management in study site activation

• Knowledge of clinical trial methodologies, ICH/GCP, FDA regulations, and applicable global and local regulatory requirements

• Experience working with Clinical Trial Management Systems (CTMS), Electronic Trial Master Files (eTMF), Electronic Investigator Site Files (eISF), and related clinical research systems

• Experience supporting investigator site activation and regulatory documentation within sponsor or CRO environments

• Familiarity with IRB and ethics committee processes and submissions

• Experience using Shared Investigator Platform and document exchange portals

• Strong communication, organization, problem solving, and multitasking skills

• Fluent or advanced spoken and written English language skills

If this job does not sound like the next step in your career, but perhaps you know someone who would be a perfect fit, send them the link to apply.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.