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 6 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 backgrounds and experience, and we value the difference it brings.

Clinical Operations is part of Clinical Development. Clinical Development is responsible for end-to-end clinical project activities, including clinical operations, medical writing, biostatistics, data management, clinical science and clinical pharmacology. We are responsible for both human and veterinary clinical trial activities within our clinical pipeline.

ABOUT THE JOB

In the position you will work closely with Clinical Trial Managers (CTM) and the Director of Clinical Operations to manage our portfolio of clinical studies, and you will have a close working relation to our Clinical Process Manager to manage day-to-day tasks related to our study Trial Master Files. You will take a key role in managing of documents and contracts related to our clinical trials and you will support the department in a number of different tasks as detailed below. In the role you will work with external partners, CROs/vendors and KOLs to ensure smooth operations of daily activities.

KEY RESPONSIBILITIES

• Trial Master File development and maintenance including training of and support to CTMs
• Document flow, review, QC and filing/archiving of trial related documents in the TMF including collection from vendors (both paper and e-CRFs), quality and completeness processes and archiving
• Supporting the CTMs in operational aspects related to trial planning, conduct and closure to ensure compliance and quality of the clinical trials
• Working with external partners, CROs/vendors and KOLs to support document flow
• Assist the CTMs with Sponsor oversight, study specific documentation review, tracking and QC
• Liase with CROs for task follow up
• Supporting setup of contracts (CDAs, consultancy agreements etc.) with KOLs, contractors, vendors etc, including follow-up on FMV evaluations, and management of documents in our contracts management system
• Driving workflow related to our data processing agreements and DPIA assessments
• Driving compliance tasks related to vendor oversight, IT aspects, KOL reporting requirements etc.
• 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

• You have a relevant background and at least 3 years experience from working in similar positions within Pharma Industry. You have a good understanding of GCP and clinical trial conduct. Experience working with TMFs and/or contracting processes will be an advantage.
  
  It is key to us, that you have a strong quality mindset, and work in a structured and independent way.
  
  As a person, we expect you to:
  
  
  • Be detail oriented, pragmatic and support oriented
  • Be a team player, focused on the overall success of the team, the project, and Pharmacosmos
  • Be 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 IT 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

ADDITIONAL INFORMATION

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

The job is located in Holbæk, Sjælland.