Clinical Trial Manager with medical writing experience

Would you like to help develop new vaccines to control global health problems? Are you passionate about clinical trials? Are you an experienced clinical trial manager ready for new challenges? Then you may be our new colleague in Department for Vaccine Development at Statens Serum Institut.

About the Department for Vaccine Development
We develop new vaccine candidates and adjuvants to control important health problems such as tuberculosis, chlamydia, and SARS-CoV-2. We have pilot plant facilities where we produce test items for toxicological studies, and investigational medical products for clinical trials. We collaborate closely with leading research institutions around the globe. A great part of our work is funded by grants. The Department comprises 65 employees, and we are organized in 4 sections, including the Section for Clinical and Non-Clinical Development.

About your role
We are currently looking for an experienced Clinical Trial Manager with medical writing experience to join the Section for Clinical and Non-Clinical Development. The Section consists of 5 employees and a Section Manager. We are responsible for toxicology studies and clinical trials in phase 1 and 2 in Europe and Africa. Many of our activities are conducted in close collaboration with CROs. You will work in a stimulating environment in close contact with investigators, researchers, and other colleagues at Statens Serum Institut. You will have many and varying tasks, including:

• Trial management activities from planning and start-up through close-out, including keeping an eye on budget and timelines
• Providing input to trial designs
• Selection and oversight of vendors
• Risk assessment
• Shipment of IMP
• Improving and updating processes and tools, e.g. standard operating procedures
• Updating stakeholders on trial-related milestones, risks, and action plans
• Writing various regulatory documents such as clinical trial protocols, investigator’s brochures, clinical trial reports, and publications.

Your education, experience, and personal qualifications
You have an MSc in life science, a nursing background, or similar. You are well versed in clinical project management, clinical trial methodology, and ICH GCP. Preferably, you have experience with writing regulatory documents, e.g. clinical trial protocols. It is an advantage if you have experience with immunology.

You are structured, flexible, and have great communication skills. Furthermore, you are a team player. You have an excellent command of spoken and written English and you are able to speak and write in Danish.

We offer
We offer a job in an organization with high quality standards where continuous development of the employees is key. You will be working in an ambitious research environment. You will get passionate colleagues, ample opportunity to influence your projects, and a highly varied working day.

We are a family‑friendly workplace with a 37 hours working week, including lunch break. Statens Serum Institut is centrally located in Copenhagen with easy access to public transport.

Terms of employment
The employment is covered by fællesoverenskomst mellem Finansministeriet og Akademikernes Centralorganisation (terms of the collective agreement between the Danish Ministry of Finance and The Danish Confederation of Professional Associations)

or

gældende fællesoverenskomst mellem Finansministeriet og Lærernes Centralorganisation samt CO10 (LC/CO10-fællesoverenskomsten) med tilhørende organisationsaftale for sygeplejersker i staten mellem Finansministeriet og Dansk Sygeplejeråd

This is a full-time position. We expect you to start 01-April-2021 or as soon as possible.

Do not hesitate to get in touch
For further inquiries about the position, please contact Section Manager Per Skallerup at +45 5168 4404.

Are you interested?
Click on "Apply" and send us your application, curriculum vitae, and a copy of relevant diplomas.

Interviews are expected to be held in weeks 5 and 6.