Clinical Trial Intern

il y a 1 semaine

RueilMalmaison, France AptarGroup, Inc. Temps plein

**Date**:23 avr. 2025

**Lieu**: Rueil-Malmaison, 92, FR, 92500

**Entreprise**:Aptar Group

**Aptar Digital Health is a division of Aptar Pharma**

A global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing, and active material science solutions and services.

Aptar Digital Health/Voluntis conducts medical device’s clinical studies as a Sponsor across several therapeutic areas and which contributes to support the clinical and market access strategy of the Company, potentially with Pharma partners. This situation leads to the need of a strong management of the clinical trials where documentation, trial sites oversee and monitoring progresses are a key factor of success.

The position of the clinical trial Intern is to be able to manage the documentation part of the study conduct is done rigorously and according to Good Clinical Practices and Standard Operating Procedures with good collaboration with the study sites and the Contract Research Organization and the ADH/Voluntis teams as a Sponsor.

Under the supervision of the clinical project lead and in collaboration with the clinicial team, the CTI will:

- Ensure the studies are done in compliance with protocols, standard operating procedures, and Good Clinical Practice (GCP) guidelines.
- Monitor regular site visits to oversee the trial activities and data collection.
- Review and analyse clinical trial data for accuracy and completeness.
- Develop and maintain study timelines and budgets elaborated by the clinical project lead.
- Provide training to study staff on study protocols and GCP guidelines under delegation of the clinical project lead.
- Organize the Trial Master File
- Respond to Audit based on clinical study documentation.
- Collaborate with the sites monitor or research coordinator or investigator regarding study documentation
- Conduct source data verification and ensure data quality.
- Manage trial supplies and device accountability.
- Serve as a liaison between study sites, sponsors and regulatory agencies regarding study documentation.

Minimum requirements:
Trainee with scientific background

Knowledge of regulatory requirements and guidelines, such as Good Clinical Practice (GCP) and Medical Device Regulation 2017/745/EC.
- Certification in clinical research, such as the Association of Clinical Research Professionals (ACRP) certification.
- Knowledge of clinical trial data management systems and electronic data capture.
- Experience with site selection, initiation, management, and monitoring activities.
- Strong attention to detail and accuracy in data management.
- Understanding of medical device development processes.
- Working knowledge of medical terminology.
- Project management and leadership skills with attention to detail.

Ability to work collaboratively with study teams and cross-functional departments.

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