Clinical Trial Manager – Desentum Oy, Espoo
29.5.2024Apply latest by 10th of June
About the job
Desentum is a small biotech company developing innovative allergen immunotherapies for respiratory and food allergies. Our first product candidate is in clinical development and more candidates are getting close to the clinical stage. The company is mainly operating using external vendors and most of the clinical activities are outsourced.
We are looking for an enthusiastic Clinical Trial Manager (CTM) to join our team as a colleague for our Head of Clinical Operations.
Main responsibilities:
- Implementing and managing new and ongoing clinical trials conducted by CROs
- Coordinating and overseeing day-to-day clinical activities and driving study timelines
- Monitoring study progress to ensure compliance with and adherence to the study plan and to identify, evaluate and rectify problems.
- Creating and overseeing the trial budget
- Managing clinical study teams
- Coordination and supervision of clinical trial monitoring activities
- Preparing and reviewing protocols, case forms and clinical study reports, and finalizing monitoring and data management options
- Coordinating applications and possible amendments to ethical and regulatory bodies
- Shipment of materials for clinical trials
- Leading the creation and maintenance of all study files, including Trial Master File, and oversight of these files
- Assuring that the clinical trials are carried out according to the trial protocol, in compliance with ICH, CFR, and GCP guidelines as well as SOPs and local regulations, as applicable.
- Preparation and updating of the SOPs for clinical trials
We offer a key role in the clinical development of biomedical next-generation allergy treatments, a place in a highly motivated, agile, and low-hierarchy team, and an independent job with an option to work remotely or at the office in Espoo. The position offers an excellent opportunity to be involved in all aspects of the clinical development including planning, implementation and reporting of the clinical trials. There is also room in the Job Description to be tailored according to your skills and specific interests.
As a CTM you must have the ability to work independently as well as communicate well with other professionals. You must also have strong written and verbal communication abilities and highly effective interpersonal skills. Excellent organizational skills and ability to focus on detail are also essential. A CTM must also possess effective leadership abilities. Ideally you should have the following background and skill set:
- Master’s degree in life sciences
- 3+ years of work experience as CTM in a pharmaceutical company
- Good knowledge of ICH/GCP guidelines and other relevant regulations and guidance documents concerning clinical trials
- Outstanding communication skills, both verbal and written
- Ability to work independently and prioritize duties
- Well-organised working style
- Ability to focus and attention to detail
- Proficient with Microsoft Office Word, Excel and PowerPoint
- Language proficiency: English is essential, Finnish is an advantage
- Willingness to travel occasionally
To apply for this job, please send your CV and cover letter by email to info@desentum.fi by Jun 10, 2024.