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Clinical Trial Assistant - IT oriented (M/F)
Global BioPhama group
Clinical Trial Assistant - IT oriented
About Our Client
This Vaud- Headquartered global Bio-Pharmaceutical group is active in drug development, GMP manufacturing of proprietary drugs and diagnostics. It is mainly focused on the development of prescription drugs that target unmet medical needs
The objective of this exiting role is to improve speed and quality of the clinical trials in optimising the processes between the clinical trial database, the clients and Contract Research Organisations. For the clinical operations department, you will be the single point of contact between the internal Clinical Trial team and the Veeva Systems teams.
This includes also teaming with the vendor in preparing the new software releases, gathering future needs and training the team.
The Successful Applicant
Your main responsibilities
- Sound experience in Veeva Vault (eTMF) Administration from Veeva Systems or another eTMF application
- Customise, fine-tune and maintain Veeva Vault Electronic trial master file
- Work in close collaboration and provide support to Veeva Vault Business administrators (CTAs) in coordination with external Veeva Systems teams
- Provide efficient training to end-users; Develop / update related training materials, SOP's and OI's
- Coordinate change management activities and validation related to new releases
- Screen / identify / communicate around potential New Technologies applications in Clinical Trials (eTMF, EDC, CTMS, eCOA,...) with the aim to increase quality, productivity and study management efficiency
- Contribute to the set up and maintenance of company International's Clinical Studies in ClinicalTrials.gov and to the Internal Clinical Study Database
- Coordinate the requests and follow-up of company International's clinical trial insurances in conjunction with our broker
- May contribute to Reporting activities as well as study tools maintenance
What's on Offer
- Degree in Life Sciences or in Business computing
- Strong experience in clinical operations eTMF solutions (Documentum, Veeva Systems,…), database management and reporting CTMS/EDC and MS-Project a plus
- Experience in Management and filing of Trial Master File content (CTA / CRA Approach)
- Analytical approach and problem solving attitude
- Ability to plan, to prioritise and to work in a multi-task environment
- Dynamic personality, open minded, agile, curious, with a strong sense of organisation
- Customer orientation and Team spirit, with ability to foster a collaborative team environment and to work effectively with others in a fast paced matrix organisation
- Excellent communication skills;
- Excellent spoken and written English and French.
- Swiss national, or Swiss resident ( permit b-c) or EU citizen eligible to Swiss work permit.
What you are not:
- IT System administrator, developer or DBA