Clinical Trial Assistant

Are you looking for the possibility to unfold your competences within clinical operations even further? Do you thrive in an innovative environment working alongside dedicated clinical research professionals? Are you a self-driven team player, who enjoys a varied and influential day at work?

Then look no further! 

We are looking for a Clinical Trial Assistant to join the Clinical Operations team. Pharmacosmos A/S is a progressive and innovative pharmaceutical company with headquarters in Holbæk, Denmark. We are on an exciting journey of global growth inventing new and innovative treatments, and right now we are expanding our team with a Clinical Trial Assistant.

About the team

We are a growing department including 5 Project Managers and a Clinical Process Manager.

The role as Clinical Trial Assistant is new to the department and we look forward bringing a new colleague to our team. The role will report to Director of Clinical Operations.

Our team culture is characterized by fast pace, always striving for quality, respect towards each other and a high level of professionalism. We come with various background and experience, and we value the difference it brings.  

Clinical development is responsible for end-to-end clinical project activities, including clinical operations, medical writing, data management, biometrics, and contract management. We are responsible for both human and veterinary clinical trial activities within our clinical development program.

About the job

To be successful in the role, you will use your competences and experience from similar positions, to help setting up and maintaining our sponsor Trial Master files (TMFs). In the position you will be responsible for the documentation of clinical trials with emphasis on document handling, QC and archiving. You will be supporting the CTMs in various tasks as described below.

Key responsibilities

To be successful in the role, you will use your competences and experience from similar positions, to help setting up and maintaining our sponsor Trial Master files (TMFs). In the position you will be responsible for the documentation of clinical trials with emphasis on document handling, QC and archiving. You will be supporting the CTMs in various tasks as described below. 

KEY RESPONSIBILITIES

• Responsible for setting-up and maintaining sponsor TMFs
• Review, QC and file trial related documents in the TMF
• End-to end management of the global TMF, including collection from vendors (both paper and e-CRFs), quality and completeness processes and archiving
• Important player for implementation of eCRF
• Supporting the CTMs in operational aspects related to trial planning, conduct and closure to ensure compliance and quality of the clinical trials
• Assist the CTMs with Sponsor oversight, study specific documentation review, tracking and QC including review of ICF, study plans, etc.
• Ensure required study documents are submitted to the CRO.
• Liase with CROs for task follow up
• Attend internal team meetings and generate meeting agenda and minutes when needed.
• General document management and archiving tasks 

As we are a department in development, other duties may be assigned as required and we expect that you will take active part in developing the department.

About you

As a professional, we expect you to contribute with:

• A healthcare, scientific or other relevant background
• 3+ years’ experience as CTA or Trial Master File Manager
• experience in building and maintaining Trial Master Files.
• Experience in eCRF vendor selection, implementation and maintenance will be an advantage

As a person, we expect you to be:

• Detail oriented, pragmatic and support oriented
• You have a strong drive and like to take initiative
• You enjoy working in a structured and independent manner.
• Team player, focused on the overall success of the team, the project, and Pharmacosmos
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• Be able to prioritize between different tasks in a dynamic environment.
• Have a high-quality mindset.
• Have good computer skills and the ability to learn appropriate software.
• Be fluent in English, both written and spoken.

We offer

• An opportunity to join a dedicated team with many different projects ongoing
• Possibility to influence the continued development of the position and area
• Possibility to impact a growing organization

Contact

If you have questions to the position, please contact Henriette Bjarnøe, Director of Clinical Operations. Mobile: +45 2943 1937