Clinical Trial Associate

TFS is a Global CRO headquartered in Sweden. We genuinely believe that ?GLOBAL IN MIND AND LOCAL AT HEART is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory and clinical trial requirements in every country where we operate. We value a close working relation with our customers, and with our employees.

TFS is growing and expanding our team with a Clinical Trial Associate. In this position you will have the possibility of working either as an outsourced consultant at pharmaceutical, or biotech companies, or working with project assignments in-house. We are responsible for studies ranging from pharmaceutics to aesthetics, medical device and food and nutrition. The position is full-time and you will be located at TFS head office in Lund, or at one of our client?s facilities.

The Clinical Trial Associate (CTA) is part of the Clinical Operations Unit within TFS Develop and will work, when delegated, as a member of the study team with the responsibility to organize and maintain the Study Master File (SMF) and coordinate practical tasks during the study according to company policies, SOPs and regulatory requirements.

The main responsibilities of the position will include:
- Work with the Study Team in initiating, maintaining and closing/final archiving of the TMF, ensuring GCP compliance
- Set up and maintenance of study information in Clinical Trial Management System (CTMS) as per delegation from Study Team
- Maintenance of electronic files.
- Set up the Investigator?s File as directed by the Study Team
- Coordinate study supplies as directed by the Study Team
- Drafts and/or assists with the preparation of trial-related documents, tools and templates
- Assist in status reporting
- Arrange internal and external meetings
- Actively taking part in Study Team meetings and be responsible for the minutes
- Prepare, contribute to and distribute presentation material for meetings and newsletter
- Assist in activities associated with audits and regulatory inspections
- Collection of appendices for final Clinical Study Report
- Actively contribute to the organization and development of routines to enhance the work at TFS
- Work with the Study Team in all regulatory process (IEC/IRBs/CA ) including submission and amendments, regulatory fees
- Assist in managing contracts with sites, including contract status.
- To manage Investigator Payments as directed
- Assist the PL with document translations process
- May support the CRAs with some monitoring remote activities: collection of documentation, follow up on data entry, queries resolution
- May work with vendor management and act as support in financial issues.

Requirements/Qualifications:
- Bachelor?s Degree preferred
- A few years? experience from working as a CTA.
- Good knowledge of GCP/ICH guidelines
- Experience from working with eTMF
- Good written and communication skills both in English and Swedish
- Good organizational skills
- Able to work in a fast paced environment with changing priorities
- Good software and computer skills

We are looking for team oriented candidates who are flexible, service minded and with good interpersonal skills. As a person you exhibit attention to details and have good organizational skills. You enjoy working in a fast paced environment with changing priorities.

For more information about this vacancy please contact:
Maja Lindeblad, Sr Recruitment Associate, +46 721 561302.