Clinical Study Start-up Specialist
For our customer, a prestigious and well-known pharmaceutical company, we search for a Clinical Study Start-up Specialist (m/f) who will be responsible for activities related to study start up and ongoing study document management.
The study start-up specialist
- Independently manages multiple country, study and site level deliverables during start-up and maintenance
- Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones
- Prepares Investigator Sites to conduct clinical trials : review and obtain approval for essential clinical trial and regulatory documents
- Supports local regulatory in preparing and performing submissions for Health Authorities and Ethics Committees and ensures the follow up
- Collaborates with other internal roles in country feasibility and site selection.
- Prepares country Informed Consent Form (ICF) and manages country ICF template
- Reviews and approves Clinical Trial Package (CTP) documentation
- Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management
- Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal
If you already have 3-4 years experience in that domain, you will also be asked to :
- Represent your company in local (e.g. pharma association or HA driven) working groups around start up processes in the country
- Represent your company in meetings discussing local requirements / repetitive questions from local Health Authority and Ethics Committees
- Proactively work with stakeholders (e.g. document template owners, GRS, CMC, CSO) to prevent questions from HA based on observed past questions. You will constantly analyse the SSU process, looking for innovative ways to introduce efficiencies in order to speed-up start-up timelines, whilst maintaining quality.
The ideal candidate
- Has a Bachelor or Master degree (required). Field of study within life sciences or equivalent
- Is perfectly trilingual (or Dutch native speaker with a good command of French and English)
- Has a thorough understanding of GCP, ICH Guidelines and Country regulatory environment
- Has an in-depth knowledge and understanding of clinical research processes, regulations and methodology
- Shows demonstrated organizational and planning skills and is an independent decision-maker
- Has strong organization and time management skills and is able to effectively manage multiple competing priorities
- Has a critical thinking and is able to conduct a risk analysis.
- Has good verbal and written communication skills (both in English and local languages).
What can you expect ?
- A contract of undetermined duration with our customer, a famous pharmaceuticals company
- A motivating salary
- Evolution possibilities
- A nice working environment
- The possibility to work 50% from home
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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