CLINICAL PROJECT MANAGER
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 Clinical Project Manager for a permanent-term contract in Kuopio or potentially other location in Finland. 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 clinical team of the company. As a Clinical Project Manager, you are responsible for the planning, preparation, execution, and management of clinical studies according to the required quality standards, on schedule, and within budget. You will oversee and manage the activities of CROs and are responsible for the preparation of relevant clinical documents (Clinical study protocols, manuals, IB, IMPD, CTA, design of eCRF). Your primary task is to manage our product AUP-16 phase 1-2A clinical studies in venous ulcer, pressure ulcer, and/or other non-healing wounds. You will report to the Chief Medical Officer of the company.
Your previous work experience and knowledge define 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.
- Development of study protocols and other study related documents by coordinating input from internal team members and external sources.
- Implement trials, including CRO selection, feasibility studies, investigator identification, timeline management, investigator communication, monitoring, and budget maintenance.
- Oversight of clinical trial operations as performed by a CRO or other external consultants.
- Evaluate potential vendors, negotiate budgets, and finalize contracts.
- Preparation and set-up of internal SOPs related to GCP requirements.
- Manage multiple clinical studies according to GCPs, SOPs, protocol, and local regulations.
- Develop tools and processes that increase measured efficiencies of the project.
- Track items related to CDAs, budget, and contract completion status.
- Bachelor/Master’s/PhD degree in Life Sciences or health-related field required. Other educational qualifications may be accepted in relation to experience in managing clinical programs and studies.
Qualification & Preferred Experience:
- Minimum of 5 years of experience in all operational aspects of managing clinical trials in a leadership role using CROs (protocol development, study implementation, study management, monitoring, and study report preparation).
- Minimum of 2 years of experience managing external vendors and CROs.
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 us 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