Aurealis Therapeutics is a Swiss-Finnish private biopharmaceutical company focusing on the development of a 4-in-1 synthetic biology, cell and gene therapy platform to address unmet medical needs in three therapy areas: chronic wounds, oncology, and inflammation.
We at Aurealis Therapeutics are looking for a Medical Monitor for a permanent-term contract in Kuopio or potentially other location in Finland, the Netherlands, Germany, or Switzerland. The start date of the job is negotiable, but we wish you could start during the first quarter of 2023. You will be working full-time.
We are looking for a team player for the medical monitoring and drug safety management of the company. As a Medical Monitor, you are responsible for medical and safety aspects of clinical development, advising and consulting on safety event evaluation, providing physician-level opinions on multiple trials and sites, consulting on protocol design, patient safety concerns, deciding if a specific adverse event requires unblinding, mediating between sponsor, CRO and trial sites, reviewing whether concomitant medications and adverse events are coded and reported properly, examining the protocols of a clinical study, planning and initiating a trial, dealing with the data (analysis, interpretation, exploration). You are also responsible for pharmacovigilance/drug safety (Drug Safety Officer).
Your previous work experience and knowledge defines your position and responsibilities, so you have the opportunity to affect your role. Successful candidate for this role must be able to communicate efficiently in English.
We hope that you have at least +2 years of experience in similar roles and in depth, hands-on experience and understanding of clinical trial execution and follow-up. You have a degree in Medicine (MD). Working experience in chronic wound indications is an advantage, but not a must. You would be reporting to our Chief Medical Officer, and working closely with the clinical and regulatory teams and with external service providers (CROs). You are collaborative, highly organized and enjoy working with different systems. If so, you might be our new colleague!
Experience and skills required:
- Overall knowledge and experience of the drug development process, clinical trial conduct, data management, drug safety, and biostatistics
- Deep knowledge of relevant regulations e.g., ICH/GCP/GVP, EMA, and FDA guidelines
- Excellent organizational, decision making and project management skills
- Experience in working with software programs (EDC, eTMF, etc.)
We will offer you a position in an international and dynamic working environment where you have the opportunity to develop your career path. Join our team!
If you are interested in the position, please send your application by filling out the form below. We will be interviewing during the application time.
If you have any questions regarding the position, please contact Maija Rusi, our Financial and Administrative Director, by email at firstname.lastname@example.org