Senior Field Clinical Specialist

Buscojobs; Lombardia; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An innovative med-tech company is seeking a Senior Clinical Research Associate to manage Europe-based clinical trials. This role involves training staff, providing technical support during procedures, and ensuring compliance with protocols. You'll play a crucial role in enhancing patient outcomes through cutting-edge technology. The ideal candidate will have a strong background in clinical research and medical devices, along with excellent communication skills. Join a forward-thinking team dedicated to improving healthcare solutions and make a significant impact in the medical field.

Competenze

• Bachelor’s degree in life sciences or related field; Master’s preferred.
• Experience in clinical research, medical devices, or CROs.

Mansioni

• Train site staff on device usage and study protocols.
• Manage trial activities from initiation to close-out.
• Assist in EC / IRB submissions and audits.

Conoscenze

Clinical Research

Proctoring

Data Management

Communication Skills

Organizational Skills

Knowledge of GCP

Fluent in English

Knowledge of ISO 14155

Formazione

Bachelor's degree in life sciences

Master's degree in life sciences

Strumenti

eCRF systems

Descrizione del lavoro

Our client is an innovative med-tech company focused on developing diagnostic and therapeutic solutions to restore microvascular blood flow. Our mission is to improve outcomes for patients with Acute Coronary Syndrome (ACS) through cutting-edge technology. Following successful clinical trials, we’re expanding our team to support ongoing and future studies, including international trials.

Job Description :

We’re looking for a Senior Clinical Research Associate (SCRA) or Senior Field Clinical Trial Specialist (SFCTS) to manage and support our Europe-based clinical trials. The role focuses on proctoring duties, including training study staff and providing technical support during live cath lab procedures. You will also ensure proper device usage and protocol adherence, helping to drive the success of our pivotal trials.

Key Responsibilities :

1. Proctoring & Case Support :
   • Train site staff on device usage and study protocols.
   • Assist with case setup to ensure data consistency and quality.
   • Provide remote or on-site support during live cases.
   • Maintain accurate proctoring records.
   • Release sites to independent device use, in collaboration with the Clinical Project Manager (CPM).
2. Clinical Trial Support :
   • Manage trial activities from initiation to close-out.
   • Educate staff on the study’s protocols and data management systems.
   • Perform site visits for qualification, monitoring, and compliance.
   • Collaborate with study teams to resolve issues and ensure timely data collection.
3. Regulatory Support & Data Management :
   • Assist in EC / IRB submissions and audits.
   • Ensure timely and accurate data entry in eCRF systems.

Desired Qualifications :

• Bachelor’s degree in life sciences or related field (Master’s preferred).
• Experience in clinical research, medical devices, or CROs.
• Proctoring experience preferred.
• Fluent in English and at least one other European language (French, Spanish, or Italian).
• Knowledge of GCP, ISO 14155, and EU regulations.
• Strong communication and organizational skills.
• Willingness to travel up to 60-80% within the EU.

Location :

Clinical Specialist • Monza, Lombardy, Italy