Do you thrive in supporting the development of new drugs for patients? Do you want to make a difference in the development and execution of clinical trials? Are you driven by supporting a team and at the same time like to have responsibility for your own tasks – then this could be a role for you.ALK is growing and is now looking for a Clinical Trial Assistant to join our Clinical Project Management team within Global Clinical Development.
The position
As a Clinical Trial Assistant, you will be part of ALK’s Global Clinical Development area, which drives the company’s global clinical project portfolio. This is an excellent opportunity for someone who has experience from a similar role and wants to be part of a dynamic, collaborative and growing team.
You will work closely with the Clinical Project Managers, fellow Clinical Trial Assistants, and other key roles in the cross functional trial teams.
This role offers a broad variety of assignments in an ever-changing environment; all focused on supporting the process of getting new innovative allergy treatments to the market and ultimately improving the quality of life for the millions of patients worldwide.
Your primary tasks will include:
- Coordinating and actively participating in reviews of Clinical Trial agreements and similar agreements in close collaboration with the clinical team, legal department and CRO.
- Actively contributing to building the CTA department by ensuring alignment in processes and compliance across clinical trials.
- Managing trial documentation e.g. trial relevant logs, meeting minutes, actions, issues, and decisions.
- Responsible for setting up, maintaining, and ensuring the quality of the Trial Master File (TMF).
- Assisting with updates to trial documents and trial budgets.
- Executing trial related tasks in collaboration with the Clinical Project Manager and relevant stakeholders in accordance with the responsibility split throughout all phases of trial conduct.
- Executing on department related tasks in collaboration with relevant internal stakeholders.
- Contributing to the development, maintenance, and implementation of procedures and instructions within Clinical Project Management and Global Clinical Development.
Your profile
You bring experience from a similar role within the pharmaceutical industry/CRO and have a flair for and interest in legal agreements or even have a background as legal assistant or paralegal. You are structured, detail oriented, and enjoy coordinating multiple activities while working closely with others.
You are motivated by variety in your daily work and by contributing to the development of innovative treatments that make a real difference for patients.
We imagine that you:
- Have a relevant education and solid experience of administrative and coordination assignments.
- Have a strong theoretical and practical knowledge of clinical trial management.
- Have solid experience with clinical documentation and document handling.
- Have experience with GCP and/or pharmacovigilance.
- Have knowledge of applicable regulations, guidelines, and directives within clinical studies.
- Are fluent in spoken as well as written English.
- Have strong IT skills and confidence working with clinical systems. Excellent written and verbal communication skills.
Become a part of ALK
ALK provides a dynamic and pleasant work environment with inspiring and challenging assignments. The results of your efforts will have a visible impact across the organisation, and you will have the opportunity to influence and improve ways of working.
Our flat organisational structure attracts independent individuals who like being close to decision-making and seeing the impact of their work. We value an attractive working environment conductive to both professional growth and personal development. You will be part of an engaged and informal team. who values skill and knowledge creation.
ALK is more than just a pharmaceutical company; ALK is a community dedicated to improving the lives of people with allergies. With over a century of leadership in allergy immunotherapy, we are committed to delivering the highest standards of patient care.
Join our engaged team at our Head Office in Hørsholm, located in the scenic DTU Science Park with green surroundings. We believe that physical presence enforces strong teamwork, collaboration and creates success, so it is important that you enjoy coming to work at our site, with a degree of flexibility to also work from home.
If you want to learn more about our company, we encourage you to visit us at
[xxxxx] commit to an inclusive recruitment process and equal opportunity for all our applicants. Hence, we prefer that you do not add images to your application documents. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to close the position once the right candidate has been found.
In case you have questions, please contact Associate Director, Clinical Project Management, Berit Gorsøe Kjeldsen by phone +
[xxxxx]. We kindly ask you not to contact us with commercial inquiries.
