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Start-Up Specialist

Employer
Labcorp
Location
Brussels, Belgium
Salary
Competitive
Start date
3 Aug 2021
Closing date
30 Aug 2021

View more

Discipline
Clinical Research, Study Start Up
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


We are currently recruiting for a(junior) Start-up Specialistto join our team inBelgium. You will be part of ourmulti-sponsorstructure and work with multiple vendors, drive and coordinate activities across a range of stakeholders in support of site start-up delivery.

Essential Duties and Responsibilities:

- The 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 Labcorp regulatory regarding document submission requirements

- Perform other duties as assigned by management
Education/Qualifications:
- 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)

- Fluency in Dutch and English and French
Experience:
- (junior)Start-up Specialist: Minimum 0,5 year of experience in clinical development or regulatory process

- Start-up Specialist: Minimum 1,5 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

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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