As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

Join us as we speed the delivery of ground-breaking therapies and anticipate tomorrow's drug development challenges, creating new possibilities for our clients and your career.

Vacancy Details:

In this role, you will have a permanent and full-time contract. You can be based in Lithuania, Latvia or Estonia.

Study Start Up Specialist is responsible for country study start up (SSU) activities and performing quality review of essential documents; responsible for overseeing and leading SSU activities in collaboration with country team members with the objective to improve site activation and maximize patient recruitment time.

The SSU Specialist is responsible for the start-up of clinical trial activities in their assigned country/countries to achieve greenlight for selected sites. Specialist also performs quality review of essential documents at start up and during the lifecycle of the study, ensuring adherence to ICH-GCP guidelines, local requirements and QSDs.

Major Tasks:

• Interact with site and study personnel to collect country specific documents such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. and review for accuracy, completeness and adherence to ICH/GCP and QSDs
• Perform quality review of country and site level essential documents following a risk-based approach, issue queries, and communicate outcome to identified users at key milestones and during the course of the study
• Prepare and submit regulatory and IRB/IEC documentation as required per country requirements and QSDs during the course of the study
• Preparation, tracking, and distribution of site start up documentation including Investigator Site File
• Obtain any required approvals for relevant site document (e.g. informed consent, financial disclosures) to ensure start up timelines are met
• Manage oversight, in collaboration with CLM, of country and site start up activities and eTMF quality using Vault Clinical reports and dashboards
• Monitor internal start up KPIs across studies and identify and communicate trends
• Support start up process improvement implementation
• In collaboration with CRA, maintain and ensure accuracy of site information in Vault
• Assist with audits/inspections of relevant start up activities and/or eTMF
• Attend and actively participate in team meetings by providing site greenlight projections and timelines
• Provide input on site activation strategy
• Ensure awareness of related local regulations and support maintenance of country intelligence in Veeva

Qualifications:

• Bachelor's degree (or equivalent) and minimum of 2 years of experience in clinical development including start up/ regulatory process experience
• Understanding of ICH-GCP essential documentation and familiarity with country specific clinical trial regulations
• Demonstrated ability to quality review documents and identify discrepancies/inconsistencies preferred
• Ability to embrace Veeva Clinical Vault system and associated functionality
• Strong written and verbal English communication skills
• Flexibility to adapt to changing business needs and priorities
• Demonstrated organization skills and attention to detail
• Strong service orientation
• Ability to work independently and manage multiple tasks and priorities

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.

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