The English-language job board for Spain

Clinical Compliance Manager

Remote from Spain·Full-time·Added 5 days ago

Parexel

3 open roles

Apply

Overview

Job details

Full-time hours
Per the ad.
Fully remote
Only from certain places, per the ad: “This will be a fully remote home-based position and is only open to applicants in the countries listed above.”

Requirements

Have the right to work in Spain
Parexel doesn't mention sponsorship in the ad.
Have 5+ years of experience
Mid-level role.

Requirements

What we're looking for

Minimum 5 years clinical operational experience, e.g. clinical trial manager, clinical compliance manager, clinical project manager, etc.
Experience 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.

The role

Parexel are currently recruiting for an experienced Compliance Manager to join one of our growing sponsors in either Poland or Spain.

What you'll do

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.

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

How you'll work

100% remote and sponsor dedicated.

This will be a fully remote home-based position and is only open to applicants in the countries listed above.

Hiring process

If you are interested, please apply or send your CV to marta.kuniewicz@parexel.com

About Parexel

Parexel is a global biopharmaceutical services company that provides a broad range of expertise in clinical research, including clinical trial management, regulatory consulting, and patient recruitment. With over 40 years of experience, Parexel supports pharmaceutical and biotech companies in bringing new treatments to market, operating across more than 80 countries with a workforce of over 19,000 professionals.

In Spain, Parexel operates through its Functional Service Provider (FSP) model, with a significant presence in Madrid and Barcelona. The company is known for its collaborative and flexible work culture, offering international professionals the opportunity to work on global clinical trials from Spain. For international hires, Parexel offers a multicultural environment and the chance to develop a career in clinical research, with roles ranging from clinical operations to site contracts and budgeting.

Founded: 1982
Employees: 10,000–25,000
Headquarters: Boston, USA
In Spain: Madrid, Barcelona
Website: parexel.com

Good to know if you are moving

Parexel's FSP model in Spain offers a direct pathway into global clinical research, with roles focused on investigator contracts and site management.
The company's work in Spain is primarily in Madrid and Barcelona, which are major hubs for international professionals.
Parexel provides a structured career path in clinical operations, from GCO Associate to leadership roles, without requiring relocation outside of Spain.
The company's global scale means that Spanish-based employees often collaborate with international teams, offering a multicultural work environment.
Parexel is a well-known name in the biopharmaceutical industry, which can be a strong addition to a CV for those looking to stay in the clinical research field.

In their own words

About the company & team

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 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

All open roles at Parexel