Study Start Up Specialist Junior

When our values align, there's no limit to what we can achieve.
About Parexel Parexel is a leading global clinical development partner delivering insight-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 Junior Study Start-Up Specialist to join our FSP Clinical Operations team in Spain.
As an individual contributor, you will help investigator sites get ready to start clinical trials, playing a direct role in reducing site activation timelines and bringing studies to life for patients.
You will conduct and facilitate specific start-up activities, including handling confidentiality agreements, processing feasibility questionnaires, collecting and reviewing essential documents, customizing Informed Consent Forms (ICFs), and coordinating Ethics Committee (EC) and Competent Authority (CA) submissions.
You will bring regulatory, timeline, and other concerns to the attention of the Global Study Start-Up Lead and/or project team, and you will actively take part in finding solutions.
Working alongside Clinical Operations, Study Start-Up specialists, Regulatory, and contract vendors, you will help keep project-specific status and deliverables on track.
Your work will be essential to ensuring our investigator sites are prepared to start trials on time and to the standards our clients expect.
You will join a collaborative, growth-oriented environment where your contributions are highly visible and where continuous learning, professional development, and meaningful impact are part of everyday work.
Key Responsibilities Coordinate and track site feasibility activities.
Ensure confidentiality agreements (CDAs) are in place.
Collect and maintain current Regulatory and Competent Authority (CA) and Ethics Committee (EC) submission information within JVRIM and CTIS, and similar information for other related organizations, for the assigned country (for example, IRAS).
Ensure clinical trial insurance is in place for submission.
Coordinate translations of documents required for submission.
Create, review, and customize country and site-specific Informed Consent Forms (ICFs).
Work with regulatory team members and the SSU Lead to secure authorization of regulatory documents.
Work with legal, contract vendors, and the SSU Lead to secure authorization of contracts.
Collect and review initial regulatory packets and site contracts for investigator sites.
Coordinate all site activation activities, including obtaining and maintaining regulatory and ethics approvals, and reviewing and approving essential documents for IP release.
Prepare ongoing submissions, amendments, and periodic notifications required by central and local IRB/EC, CA, and other local regulatory authorities, including safety notifications required by local laws and guidelines.
Ensure all relevant documents are submitted to the Trial Master File (TMF).
Liaise with local CRA/CTM, contract vendors, and the Regulatory Lead to enable a rapid clinical trial start-up.
Inform team members of the completion of regulatory and contractual documents for individual sites.
Attend project meetings with cross-functional department leads to provide updates.
Identify site issues (risks) during the start-up process, resolve minor to moderate issues independently, and escalate and participate in the resolution of complex issues.
Escalate risks, such as timelines, to the SSU Lead or CTM, as appropriate.
Review and provide feedback to the SSU Lead on site performance metrics.
Maintain and manage SSU data tracking entries, reviewing them for completeness and accuracy.
Facilitate process improvement efforts both within the department and in cooperation with other departments.
Support the development of start-up plans and essential document checklists.
Collaborate effectively with cross-functional teams, including regulatory, legal, and clinical operations, to manage site start-up activities, ensure compliance with regulatory requirements, and facilitate efficient clinical trial initiation that aligns with project timelines and quality standards.
Complete the required training curriculum, timesheets, and expense reports accurately and on time, and keep your CV up to date as required.
Maintain a worki