Labcorp

Sr Start Up Specialist

Labcorp

Labcorp is a leading global life sciences company with a mission to improve health and improve lives. Combining world-class diagnostic solutions with its drug development business, our cutting-edge technologies, unparalleled data, and growing menu of standard and highly-specialized tests not only inform and empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Labcorp’s more than 70,000 employees are pursuing critical advances in science and changing the delivery of healthcare while advancing essential vaccines, cancer-fighting breakthroughs, and life-changing treatments for rare diseases.

Explore our careers at https://careers.labcorp.com
531 South Spring Street
Burlington, North Carolina 27215
http://www.labcorp.com

We are currently recruiting for an experienced Senior Start Up Specialist to join our team in Belgium. The role is permanent and full-time.

Responsibilities will include:

  • Provide expertise for local regulations, ICH/GCP and relevant study and Sponsor requirements.

  • Develop project specific plans for the Site Activation component of assigned studies

  • Review and approve Country and Site Specific patient informed consents for compliance to local requirements.

  • 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

Requirements:

  • Experience in both EC and Regulatory submissions (including new EU CTR submissions)

  • Experienced and willing to do site contracts negotiations

  • Fluent in Dutch, French and English

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant’s race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant’s race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

For more information about how we collect and store your personal data, please see our Privacy Statement.

If you require alternative methods of application or screening, you must approach Labcorp directly to request this, as we're not responsible for the employer's application process.

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