Clinical Research Associate & CRA Supervisor EMEA (50/50)

Teleflex; Milano; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Teleflex is seeking a highly experienced Clinical Research Associate (CRA) with leadership responsibilities across the EMEA region. The role combines hands-on monitoring with people leadership to ensure high-quality study delivery and compliance.

Ideal candidates bring at least 10 years of clinical monitoring experience and a background in life sciences. This hybrid role supports development of CRAs while driving operational excellence in clinical operations.

Competenze

• Degree in Life Sciences, Nursing, Pharmacy, Medicine, Biology, or a related field.
• Scientific understanding of clinical research and medical devices.

Mansioni

• As CRA (50%): Execute monitoring activities per MDR, ISO 14155 and study requirements.
• Conduct Site Qualification, Site Initiation, Routine Monitoring, and Close-Out Visits.
• Perform SDV and source document review; ensure protocol and subject safety.
• As CRA Supervisor (50%): Lead, coach, and develop CRAs across the EMEA region; onboarding and training.
• Maintain audit readiness and act as interface between Clinical Operations, Quality, Safety, and Data Management.

Conoscenze

Clinical monitoring

Leadership

Mentoring

Regulatory knowledge

Study coordination

Formazione

Life Sciences degree

Strumenti

MS Office

eTMF

eCRF

CTMS

Descrizione del lavoro

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Clinical Research Associate & CRA Supervisor EMEA (50/50)

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Position Summary

We are looking for a highly motivated and experienced clinical research professional to join our Medical Affairs team in a unique hybrid role combining:

• 50% Clinical Research Associate (CRA) responsibilities

In this position, you will not only perform hands-on monitoring activities for clinical studies but also provide leadership, coaching, and operational oversight for Clinical Research Associates across the EMEA region.

This role is ideal for an experienced Senior CRA who enjoys mentoring others while remaining actively involved in study execution.

As a Clinical Research Associate (50%)

You will be responsible for the execution of monitoring activities in accordance with MDR, ISO 14155, applicable regulations, and study requirements.

Key responsibilities include:

• Conducting Site Qualification, Site Initiation, Routine Monitoring, and Close-Out Visits
• Performing Source Data Verification (SDV) and source document review
• Ensuring protocol compliance and subject safety
• Training and supporting site personnel
• Managing and maintaining Investigator Site Files (ISF)
• Supporting Ethics Committee (EC) and National Competent Authority (NCA) submissions
• Supporting safety reporting activities
• Managing study-related queries and follow-up actions
• Preparing sites for audits and regulatory inspections
• Acting as the primary contact for assigned study sites

As a CRA Supervisor (50%)

You will lead and develop a team of CRAs across the EMEA region while ensuring high-quality monitoring delivery and compliance.

Key responsibilities include:

• Leading, coaching, mentoring, and developing CRAs
• Supporting onboarding and training of new CRAs
• Ensuring monitoring activities are conducted according to plans and procedures
• Supporting resource and workload planning
• Monitoring performance and quality metrics
• Ensuring audit and inspection readiness
• Acting as a key interface between Clinical Operations, Quality, Safety, Data Management, and Project Management

Education / Experience Requirements

• Degree in Life Sciences, Nursing, Pharmacy, Medicine, Biology, or a related field
• Scientific understanding of clinical research and medical devices

Specialized Skills / Other Requirements

• Minimum 10 years of clinical monitoring experience
• Proven experience as a Senior CRA
• Experience mentoring, training, or supervising CRAs
• Strong knowledge of:
• ISO 14155
• MDR
• Clinical trial regulations and requirements

Technical Skills

• Microsoft Office
• eTMF
• eCRF
• CTMS

Language Requirements (Mandatory)

To support study sites and stakeholders across Europe, candidates must be fluent (written and spoken) in:

At least one Romance language, such as:

• French
• Spanish

Applications that do not meet all three language requirements cannot be considered.

What Makes You Successful

• Strong leadership and coaching skills
• Excellent communication and stakeholder management
• High attention to detail
• Strong organizational skills
• Ability to work independently and make sound decisions
• Collaborative mindset with a focus on quality and compliance
• Passion for developing people while driving operational excellence

Why Join Us?

This is a unique opportunity to combine operational clinical monitoring with leadership responsibilities, allowing you to directly influence study quality, team development, and patient outcomes across the EMEA region.

If you are an experienced clinical research professional who enjoys both hands-on monitoring and people leadership, we would love to hear from you.

Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community.

If you require accommodation and support to apply for a position, please contact us at [e-mail]

Diversity fosters innovative thinking and entrepreneurship and that’s what we are about at Teleflex. We trust and value our people and their diversity and we make it fun to work here. We are on a journey to ensure our workplaces mirror the patients we serve and the communities we operate in. Our approach is simple, we embrace everyone and want them to feel they belong here. We are building a culture where all employees can bring their best and unique selves to work. If that appeals to you, we would love to hear from you. Come join a company where diversity is sought out and inclusivity is how we progress.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.