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.
Parexel are currently recruiting for an experienced Quality/ Regulatory/ Compliance professional to join one of our growing sponsors in either the UK, Italy or Germany.
This position provides GCP compliance support to clinical study teams under the direction of the Sr. Manager or the Associate Director. The key activity of the role is providing expertise and guidance regarding regulatory requirements, GCP guidelines, and sponsor Standard Operating Procedures (SOPs) for the conduct of clinical studies.
The position will utilize a risk-based strategy to prioritize compliance support for clinical activities, identify and escalate compliance issues, enable decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. The Clinical Compliance Manager serves as an important conduit to the broader organization to ensure a culture of quality and compliance.
This will be a fully remote home-based position and is only open to applicants in the countries listed above.
Some specifics about this advertised role
- Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas.
- Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed.
- Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness).
- Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches.
- Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies.
- Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues.
- Participate in vendor evaluations as a Subject Matter Expert (SME) as needed.
- Support clinical teams/functions in drafting responses and CAPAs to internal and external audit findings.
- Provide support and guidance for Quality Management System activities including self-reporting deviations, root cause analysis, and CAPA plan development and evaluation.
- Identify and anticipate trends in quality issues and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion.
- Lead / manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections
Who are Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
You’ll be an influential member of the wider team.
What we are looking for in this role
- Minimum of 5 years in the academic, pharmaceutical or biotechnology industry experience, with 3+ years in a clinical compliance, quality assurance, or regulatory compliance role.
- Thorough knowledge and understanding of drug development and the clinical trial process.
- In-depth knowledge of current regulatory and ICH GCP requirements and experience with international regulations, guidelines and standards is required.
- Working knowledge of CAPA management, risk management, regulatory inspections.
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Skills Required
- Minimum of 5 years in pharmaceutical or biotechnology industry experience
- 3+ years in a clinical compliance, quality assurance, or regulatory compliance role
- Thorough knowledge and understanding of drug development and clinical trial process
- In-depth knowledge of current regulatory and ICH GCP requirements
- Experience with CAPA management and regulatory inspections
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.
