Covance by Labcorp is the drug development business of Labcorp, the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real. Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, along with our innovative technology solutions, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Covance by Labcorp has supported the pharmaceutical industry to develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today.
We are currently recruiting for a (Senior) Start-up Specialist to join our team in Belgium. You will be part of our FSPx teamone-sponsor structure and work with one well known pharmaceutical company.
Essential Duties and Responsibilities:
- The (Senior) SU Specialist proactively anticipates and mitigates issues that could delay start up across a range of sites
- Provide expertise for local regulations, ICH/GCP and relevant study and Sponsor requirements.
- When delegated by Start-up Country Manager (SUCM), oversee and ensure quality data and audit readiness
- Review and approve projections and timelines to study teams, ensuring that they accurately represent the country’s performance and suggests mitigation actions in agreement with SUCM
- Develop project specific plans for the Site Activation component of assigned studies
- When appropriate, take a lead in team meetings to resolve issues and progress the trial
- Review and approve Country and Site Specific patient informed consents for compliance to local requirements and protocol with agreement by SUCM
- Proactively resolve informed consent and contractual language issues plus other significant barriers to study execution with study sites
- Oversee start up activities (possibly across a range of studies) to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual
- Liaise with Covance by Labcorp regulatory regarding document submission requirements
- Perform other duties as assigned by management
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 4 years work experience in clinical research
- Fluency in Dutch, French and English
- Start-up Specialist: Minimum 1 year of experience in clinical development or regulatory process
- Senior Start-up Specialist: Minimum 3 years of experience in clinical development or regulatory process
- Expert knowledge of investigator start-up documents; previous interaction with operational project teams and investigative sites
- Credible role model in effective communication and problem solving.
- Proven strengths managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external to the organization