- Participation to regulatory submissions
- Setting up and maintenance of the trial master file
- Preparation of Investigators Site File
- Investigators fees and hospitals invoices management
- Logistics management of studies e.g. documents
- Creating/updating tracking tools
- Mailings, phoning, hotline
- Archiving of study documents
- Organization of investigators meetings
- Organization of meetings with the Sponsor
- Project meetings (organization, participation and minutes)
- Respect of quality commitments
- Participating in the continual improvement of the Quality System
- Identifying and to record non conformities
- Good level of English (spoken and written)
- Knowledge of GCP and ICH Guidelines
- Good command of office software (Excel, Word, P
- Attention to detail
- Organised, pro-active, autonomous
- Good interpersonal skills
- Good oral and written communication
- At least two years study after High school diplomao
- At least a first experience as administrative assistant (ideally in Pharmaceutical Industry)
What We Offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.