Study Start Up Specialist Junior - Spain - 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 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 working knowledge of, and comply with, Parexel processes, ICH-GCPs, and other applicable requirements.

Candidate Profile

You'll Thrive In This Role If You Bring

• The ability to work independently in a fast-paced environment
• The ability to identify and resolve site issues independently, and to escalate complex problems effectively when necessary, contributing to efficient risk management
• Flexibility and a willingness to support process improvement efforts, adapting to changing requirements and collaborating across departments to enhance overall efficiency
• Excellent verbal and written communication skills, with the ability to liaise effectively with diverse stakeholders, including CRAs, CTMs, regulatory authorities, and cross-functional team members
• The ability to collaborate effectively with cross-functional teams, including regulatory, legal, and clinical operations

Required Qualifications

• Bachelor's degree or 3 years' clinical research or other relevant experience, or an equivalent combination of education, training, and experience
• Pharmaceutical or related industry experience
• Previous experience working in a start-up team, as a Clinical Trial Specialist, or in a similar role, having worked on global clinical trials
• Excellent knowledge of GCP and regulations

Preferred Qualifications

• Experience with in-house trials or process design

Benefits and Compensation 

• Premium salary.
• Attractive benefits.
• Medical care plan: Health, Dental & Vision.
• Life Assurance.
• Excellent work environment.
• Culture of teamwork and collaboration.
• People who motivate and face challenges together.
• Innovative technology.
• Excellent training.

The potential base pay range for this role is EUR 30,000 to 32,000.
The actual salary offered may vary within this range based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.
Some roles may also be eligible for additional incentives, bonuses, or other compensation programs.
Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions. 
We offer a comprehensive benefits package to eligible employees, which includes paid time off, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans. 

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.