Farmacist/ IMP responsible Clinical trials

ARENSIA is a privately owned clinical Research Organization (CRO), with German ownership. The corporate office is in Dusseldorf, Germany and the clinical operations are in Romania, Republic of Moldova, Ukraine and Georgia.
ARENSIA performs exploratory clinical trials in dedicated Phase I set-up (clinical pharmacology units), in collaboration with reputed university hospitals in Bucharest, Chisinau, Kiev and Tbilisi.
ARENSIA clients belong to largest multinational pharmaceutical companies.
The working environment is very dynamic, entirely focused on exploratory clinical trials in various patient populations (Phase I /II /PROOF OF CONCEPT). ARENSIA is specialized to perform highly scientific protocols, with intensive PK/PD schedules and complex biomarker research.
The company is under organic expansion in Central and Eastern Europe.

The candidate profile:
- General Pharmacist / Pharmacist assistant by education.
- While the offer is targeting experienced pharmacists our organizational setup and on boarding training allow us to consider also beginners with no experience as well as pharmacist assistants with good English skills and more than 5 years of relevant experience.
- Fluent in English written and spoken (other languages are of advantage); this is absolutely mandatory, as all written company communication is in English
- The working environment allows freedom of decision linked to high level of responsibility
- This position requires excellent communication skills, perseverance, pragmatism, a “problem solver” mentality

We offer a pleasant working atmosphere, within a young, dynamic team under the leadership of a pragmatic management, with expertise in early clinical development for more than 15 years.
Description of job:

IMP responsible is taking care of the proper handling and storage of any medication (lnvestigational medicinal product (IMP), Standard-of-Care (SoC) medication, concomitant medication, emergency medication etc.) which is stored at the unit. Special focus is asked from the IMP responsible in regard to maintain the blinding of IMP in case unblinded trial medication was received.

Responsibilities:

• Ensure that the medication is stored as required by labelling
• Manage the IMP inventory (orders, replacements and return of IMP and IMP related study materials, as required)
• Perform IMP distribution activities in accordance with respective trial protocol
• Maintain information and record keeping related to IMP required by the trial protocols ("pharmacy binder'')
• Prepare intravenous products in accordance with instruction to use
• Maintain the clinical investigational work areas in a clean and orderly manner
• Maintain of temperature log for drug storage room and pharmaceutical fridge
• Liaises with external agencies/organizations, as required in regard to medication related issues

This position reports into the Medical Director, located in Romania.

We offer competitive salary package.