Study Start Up Specialist

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Study Start Up Specialist 

POSITION PURPOSE:

Study Start Up Specialist is responsible for country study start up (SSU) activities and performing quality review of essential documents.  The SSU Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) 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 Bayer QSDs. 

ROLE AND RESPONSIBILITIES:

• 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 Bayer 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  Bayer 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

WHO YOU ARE:

• The incumbent should have a Bachelor’s degree (or equivalent experience) 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

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