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Senior Start-Up Specialist

Employer
Labcorp
Location
Milan, Italy
Salary
Competitive
Start date
19 Nov 2022
Closing date
13 Dec 2022

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

Job Details

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.

Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required.

Ensure efficient in country execution and local improvements aligned with global requirements.

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.

Ensure appropriate systems are updated accurately and compliantly, with site information and study dates (projected and actual) ensuring others follow established processes.

Coach other start-up team members.

Perform other duties as assigned by management.

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 .

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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