EastHORN Clinical Services in CEE Ltd is a clinical contract research organisation (CRO) serving global pharmaceutical and biotechnology companies in the development of new medicines. The company has operations throughout Central and Eastern Europe. Since starting 12 years ago, we have grown and have established operations in more than 15 countries.

Our international clients value our enthusiastic and flexible approach to meeting their needs and we are growing rapidly. To support our further growth we are looking for a

Clinical Project Administrator, office-based in Cologne, Germany

Job summary:

As an experienced Clinical Project Administrator, you will be expected to provide clerical support to project team and assist in project management activities working with Project Manager or Project Director.

You will be involved in key activities, such as collecting and submitting documents to Regulatory Authorities and Ethics Committees Reporting to the Clinical Operations Manager, you will be an important member of the Clinical Operations team in Germany.

Main Tasks include, but are not limited to:

• Provides support and coordination in the following functional areas: investigator site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation

• Acts as contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs)

• Provides clerical support to project team (e.g., word processing, proofreading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.)

• Assists in project management activities working with Project Manager or Project Director (i.e. organizing meetings, taking minutes, following up on outstanding issues with the study team members; financial data collection and tracking)

• Sets up and maintains clinical investigator files and documentation

• Prepares investigator budget payments and tracking systems; generating tracking reports as assigned

• Performs data entry and maintenance of selected study tracking databases

• Prepares monitoring visit documentation for Clinical Research Associate

• Prepares study-related documents and other materials for delivery to archives, at appropriate intervals

• Performs other administrative duties as assigned by management

Competencies

• Life science or medical educational background or experience

• Experience in clinical trials

• Knowledge in Regulatory submissions is considered an advantage

• Ability to work well within a team

• Advanced computer literacy

• Diploma of secondary education or equivalent

• Excellent organizational and time management skills to handle multiple priorities

• Excellent written and oral communication skills in German and English

We offer:

• Working in a young and very professional team

• Possibility to gain experience in various clinical research projects and therapeutic areas

• Possibility to grow within the company

• Flexible approach to work time

• Competitive remuneration

• Eligibility to Bonus scheme, available in the company

If you are a reliable and positive personality and would like to contribute to the further success of a dynamic young company in a growing market, please send your CV and motivation letter in English to: careers@easthorn.eu

 

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