Country Study and Study Start-up Specialist

• Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures
• Executes all start-up activities prior to site activation on assigned studies
• Prepares country level Informed Consent Form (ICF) and obtains ethics committees’ and local regulatory authorities’ approval
• Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement
• Submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions
• In collaboration with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required
• Provides input into and/or develops study related materials such as Monitoring Plans, Recruitment
  Plans and Study Newsletters
• Supports/coordinates the negotiation of site budgets,
  budget plans and provides oversight for site payments per contract
• Works with global study team and CSM to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of nonproductive sites and tracking of safety procedures
• Supports management of country-level Trial Master File (TMF) and reviews for quality (including
  translations, as applicable)
• Provides feedback to local vendor manager and CSM on CRAs, and local supplier/vendor performance

• University degree or equivalent in a medical/science-related field 
• Experience demonstrating knowledge and understanding of clinical trials
• Monitoring experience is desirable
• Demonstrated knowledge and understanding of ICH-GCP, as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials
• Trilingual: FR-DU-EN

• Challenging projects based on your interests and skills
• Personal follow-up and clear, transparent communication both before and after commencement of employment
• Possibility to follow extra training
• Inspiring network events and legendary after work drinks
• Strong network of industry leading clients
• Expertise within IT, Engineering and Life Sciences
• A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

Bezoek pauwelsconsulting.com voor meer informatie over de vacature Country Study and Study Start-up Specialist of solliciteer online op de vacature Country Study and Study Start-up Specialist.

https://ift.tt/2HzGRmR