Senior CRA

QPL IQVIA RDS Poland Sp. z o.o.; England; Presencial; GBP 42 000 - 65 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Senior CRA to join its Clinical Functional Service Partnership (CFSP) team. The role involves site qualification, initiation, monitoring, and close-out visits across sponsors, ensuring patient safety, data integrity, and protocol adherence.

You will build strong relationships with investigators, support recruitment strategies, and maintain inspection-ready documentation. The ideal candidate has 4+ years of on-site monitoring in CRO/pharma, solid GCP/ICH knowledge, and the

Qualificações

• University degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or related discipline.
• Minimum 4 years on-site monitoring experience in CRO/pharma environments.
• Strong knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
• Preferrable experience in sponsor-dedicated CFSP environment.
• Knowledge of patient recruitment and study start-up activities is preferred.
• Excellent communication, organizational and stakeholder management skills.
• Ability to work independently, manage multiple priorities and collaborate across cross-functional teams.
• Willingness to travel within the assigned region (up to 40-60%).

Responsabilidades

• Conduct site qualification, initiation, monitoring, and close-out visits per study protocols, GCP/ICH and regulatory requirements.
• Ensure sites maintain patient safety, data integrity, protocol compliance and study quality.
• Build and maintain relationships with investigators and site personnel; provide guidance and support.
• Monitor study progress including regulatory docs, recruitment, data queries, and site performance metrics.
• Collaborate with sites to optimize patient recruitment and retention to support timelines.
• Maintain inspection-ready study documentation (ISF, TMF, monitoring reports).
• Identify, assess, and escalate study risks, site issues, and quality concerns; drive timely resolution.
• Partner with cross-functional study teams to support execution and delivery of objectives.
• Mentor junior team members through coaching and co-monitoring activities.
• Contribute to continuous improvement and support start-up, maintenance, close-out, and site finance activities.

Conhecimentos

GCP & ICH knowledge

On-site monitoring

Stakeholder management

Communication skills

Travel readiness

Formação académica

University degree in Life Sciences or related field

Descrição da oferta de emprego

Why Join Clinical Functional Service Partnerships (CFSP)?

At IQVIA, our Clinical Functional Service Partnership (CFSP) model gives you the best of both worlds: the variety and sponsor-level exposure of working as an embedded member of a leading pharmaceutical or biotechnology team, backed by the stability, global infrastructure, and career support of IQVIA. You'll develop deep, specialist expertise on a dedicated program, with the flexibility to expand across sponsors and therapeutic areas as your career progresses - and the security of a long-term IQVIA career even as individual programs evolve. Through our long-standing partnerships with the world's leading pharmaceutical and biotechnology companies, you'll contribute to clinical research programs that bring innovative treatments to patients worldwide, working across all phases of development and a broad range of therapeutic areas, within a culture that supports flexibility, continuous learning, and wellbeing.

Key responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, GCP, ICH guidelines, and applicable regulatory requirements.
• Ensure investigational sites maintain high standards of patient safety, data integrity, protocol compliance, and study quality.
• Build and maintain effective relationships with investigators and site personnel, providing ongoing guidance, training, and support throughout the study lifecycle.
• Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution, and site performance metrics.
• Collaborate with sites to implement and optimize patient recruitment and retention strategies to support study timelines.
• Maintain accurate, complete, and inspection-ready study documentation, including Investigator Site Files (ISF), Trial Master Files (TMF), monitoring reports, and follow-up communications.
• Identify, assess, and appropriately elevate study risks, site issues, and quality concerns while driving timely resolution.
• Partner closely with cross-functional study teams to support successful study execution and delivery of project objectives.
• Mentor and support junior clinical team members through coaching, training, and co-monitoring activities, as applicable.
• Contribute to continuous improvement initiatives and support study start-up, maintenance, close-out, and site financial activities as required.

What you’ll bring

• University degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related discipline, or equivalent combination of education and experience.
• 4 years minimum on-site monitoring experience of clinical trials within a CRO, pharmaceutical, biotechnology, or healthcare environment.
• Strong knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
• Preferrable experience in a sponsor-dedicated or cFSP environment.
• Knowledge of patient recruitment and study start-up activities is preferred.
• Excellent communication, organizational, and stakeholder management skills.
• Ability to work independently, manage multiple priorities, and collaborate effectively within cross-functional teams.
• Willingness to travel within the assigned region (up to 40-60% of working time).
• Please note this position cannot offer visa sponsorship, candidates must hold right to work in UK & Ireland.

Build Your Future with IQVIA

As a Senior CRA at IQVIA, you'll apply your clinical research expertise to drive meaningful outcomes for patients and sponsors around the world. You'll work on innovative studies across a variety of therapeutic areas, collaborate with industry-leading professionals, and take on increasingly strategic responsibilities throughout the clinical trial lifecycle. With continuous professional development, global career opportunities, and a culture that values expertise and innovation, IQVIA provides the platform to elevate your career and make a lasting impact on healthcare.

#LI-ADAMTHOMPSON

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments.

Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.