Senior Sponsor CRA M/F (M/F)

TempoPHARMA is recruiting on behalf of its client, a leading hospital establishment in the Grand Est region, a Senior Sponsor CRA M/F as part of a pre-hiring process.

Your missions

Under the responsibility of the Internal Promotion Manager, your missions will notably include:

• Ensuring the quality control of study data for internal promotion across all investigator sites;
• Verifying the regulatory compliance of documents at the various sites;
• Controlling the adequacy of clinical data entered into Case Report Forms with the data present in the patient's medical record;
• Verifying the reporting and follow-up of serious adverse events (SAE) to the sponsor;
• Conducting study site initiation and close-out visits;
• Ensuring regular follow-up of investigator sites and supporting teams in compliance with procedures and protocol requirements;
• Participating in project reviews and their operational preparation;
• Contributing to the drafting and updating of study documents: Case Report Form, data entry guide, monitoring plan and manual;
• Participating in the logistical organization of clinical trials;
• Ensuring internal SAE follow-up, in collaboration with the pharmacovigilance and materiovigilance teams;
• Participating in the drafting and updating of quality documents related to clinical research activities;
• Working in close collaboration with the Internal Promotion Project Manager and the various interlocutors at the investigator sites.

Your profile

With higher scientific or medical education (minimum Bac+5), you have at least 5 years of experience as a Sponsor CRA.

You are notably recognized for:

• Good knowledge of the regulations applicable to clinical research;
• Confirmed experience in monitoring and follow-up of investigator sites;
• A good understanding of the issues related to data quality and regulatory documentation;
• Proficiency in office tools;
• Scientific English allowing you to understand and exchange on scientific documents and topics;
• Strong organizational and planning skills;
• Good writing skills.

Additional information

• Start date: October 2026
• Position based in Metz
• Up to 2 days of teleworking per week, depending on activity and the number of travels
• Engineer status