Clinical Trial Manager

The position
The candidate will be part of the clinical team ensuring that Acarix´ clinical efforts within coronary artery disease are executed timely and effectively. Oversight, planning and implementation of clinical studies in Europe and outside of EU can also be part of the scope.

The position will also include both scientific/medical writing for regulatory purposes and to foreign authorities and provide support to our marketing/sales department in translating clinical data to presentable clinical marketing material.

Travel in connection with clinical activities and conferences or occasional user visits will be part of the position.

Responsibilities

• Writing and reviewing clinical protocols and applications and handling follow up communications including reports.
• Writing and reviewing of scientific publications/medical reports.
• Ensuring necessary documentation and instructions for the clinical sites.
• Online and occasional onsite monitoring of clinical sites incl. contact to CRO´s and suppliers where applicable.
• Data consolidation, analysis and reporting internally as well as externally.
• Support in general to the wider aspects of medical affairs and related stakeholders, here under KOLs, study PIs, and authorities.
• Support to the Acarix marketing/sales organization by training and education on related clinical study data and marketing material.

The candidate
Your educational background is within life-sciences and you have gained a solid experience working in the clinical area for at least five years, preferably within pharma and/or medical devices and diagnostics.

Besides your great experience within planning, executing and reporting of clinical trials you are able to work independently and have a sense for detail when needed in eg. checking monitoring data. Substantial knowledge of relevant regulations and guidelines is essential in interacting with authorities and ethics committees. You have good interactive skills when dealing with both clinical sites and work colleagues from other areas and are flexible and can handle a sometimes-hectic workday.

You have good communication and presentation skills in English and a Scandinavian language in both writing and orally.

The salary package is competitive and of course follows the Danish law with regards to vacation and pension.

Work home-base: Kongens Lyngby, Denmark

Personal characteristics

• Hands on approach, proactive, energetic, and self-managing
• Creative personality to get clinical messages across to different users in Acarix and beyond.
• Result oriented and likes challenges.
• Ability to build relations and cooperate across internal organization and externally.
• Thrive in a small company with broad responsibilities and short communication paths.

The product
The Acarix CADScor®System is a portable CE-marked, non-invasive medical device providing radiation-free, acoustic rule-out of Coronary Artery Disease within minutes. The CADScor®System is now in daily use in hospitals and at private practicing cardiologist.

How to apply
Please send a written application via hte "Ansøg" link, observing the rules below (as also described on the Acarix.com website “Disclaimer” section):

“Your consent is needed to process the application information under the European Union General Data Protection Regulation (GDPR) directive.

Consent is required since Acarix uses external data processors for storing and retrieving of data.

You can consent to external data processing by submitting the following consent sentence to the original email recipient:

Consent is given to Acarix to handle my sensitive personal information in relation to evaluating my application for position ID-number “C191”.

Indicate in email subject line “position number C191”, and the above information for us to proceed with your application.

You are also welcome to contact COO Claus Bo Vöge Christensen, Acarix by phone (+45 2972 4411).

Review of applications and call for interviews will start immediately.

Please write in your application that you've seen the job at Jobfinder.