Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of your project, helping you achieve your clinical and commercial objectives. Because our goal is the same as yours; to improve patients' lives.

Summary of the Position:

We are looking for a Clinical Trial Assistant to join our Clinical Operations department in France.

You will provide administrative support to the project team members in Clinical Operations and Project Management by developing and maintaining study documents utilizing company systems to manage clinical trials. You will work together with the project team to contribute to the overall quality of clinical trials and meet key deliverables as per contract and client expectations.

Key Accountabilities:

• Support with the management of clinical trials supplies (eg. CRFs, Lab supplies, Investigational Products, etc.), including the tracking and shipment of materials.
• Assist the project team with preparation, dissemination and shipment of Clinical Trial documentation including; Investigator Site File, Pharmacy File, Investigator Brochure, Protocol and study manuals.
• Manage study specific system (CTMS, eTMF, EDC, IRT, etc.) accesses for internal and external stakeholders
• Upkeep Essential Documents, ensuring documents are filed within the (e)TMF in a timely manner and contributing to applicable workflows.
• Facilitate project meetings with the preparation and distribution of materials and final meeting minutes, as well as the coordination of meeting participants.

Minimum Requirements:

Essential:

• Proficiency in written and spoken English, fluent in host country language
• Possesses practical knowledge of IT tools (Word, Excel and PowerPoint)
• Ability to establish and maintain effective working relationships
• The ability to work to tight deadlines and an ability to multi-task.

Desirable:

• Previous clinical research experience, knowledge of the industry or experience in a healthcare setting
• Previous experience with Clinical Trial systems (CTMS, eTMF etc.)
• Demonstrates a strong working knowledge of ICH-GCP

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Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.