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.
Job Summary:The Clinical Trial Submission Lead (CTSL) is responsible for end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World (ROW) regions. This role ensures timely, high-quality, and compliant submissions through effective cross-functional collaboration, proactive risk management, and strong regulatory expertise.
Key Responsibilities:
- Lead end-to-end CTA project management across multiple studies and countries
- Plan, track, and deliver submissions aligned with timelines and regulatory requirements
- Manage risks, dependencies, and complexities in global regulatory environments
- Apply knowledge of EU CTR and ROW CTA requirements
- Manage core clinical and regulatory documentation
- Collaborate with cross-functional global teams
- Build and maintain stakeholder relationships and resolve conflicts
- Monitor KPIs related to timelines and deliverable quality
- Identify risks and lead quality investigations as needed
Qualifications & Experience:
- Bachelor’s degree in Life Sciences, Pharmacy, or related field
- Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar
- Experience in Clinical Trial Application submissions (EU CTR & ROW)
- Strong project management experience in a global/matrix environment
- Familiarity with clinical trials and regulatory processes
Key Skills:
- Project Management & Execution
- Regulatory Knowledge (EU CTR & Global Submissions)
- Risk & Issue Management
- Stakeholder Engagement
- Strong communication and problem-solving skills
- Adaptability, resilience, and teamwork
Skills Required
- Bachelor's degree in Life Sciences, Pharmacy, or related field
- Minimum 5+ years industry experience in pharmaceutical, CRO, or similar
- Experience in Clinical Trial Application submissions (EU CTR & ROW)
- Strong project management experience in a global/matrix environment
- Familiarity with clinical trials and regulatory processes
- Regulatory knowledge of EU CTR and global submissions
- Risk and issue management experience
- Stakeholder engagement and relationship management skills
- Strong communication and problem-solving skills
- Adaptability, resilience, and ability to work in teams
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
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