Senior Study Startup Specialist

Company Description

PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and ontime services across a variety of therapeutic indications.

Job Description

• Coordinates study startup activities with the local project team and supports all processes critical for site activation.
• In the absence of standalone feasibility function, leads activities in feasibility research and site identification process.
• Facilitates site agreement andor budget negotiations with sites to ensure alignment to the site activation plan.
• Leads site document collection for IRBIEC submission andor IPRED process.
• Reviews studyspecific translations.
• Identifies projectspecific issues and escalates to Regional (Startup) LeadPM and operational Manager in the country.
• Under supervision prepares and submits the study dossiers to investigatorsinstitutions, competent authorities, IRBsIECs.
• Ensures quality of IPREDs packages.
• Ensures initial distribution of locally obtained clinical study supplies to sites and supervises initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites.
• Develops sitespecific startup timelines and enrolment projections and is responsible for meeting the site activation targets under supervision.
• Provides startuprelated training and methodological support to operational staff within the countryregion.
• Provides onthejob coaching of department staff.
• Supports preparation for audits on a country regional level.
• Upon completion of the project startup phase, supports the preparation of a summary on operational challenges, best practices and lessons learned, and reports to Study Startup management and other functions concerned.

• Qualifications

  • Universitycollege degree, or an equivalent combination of education, training, and experience​
  • At least 4 years’ experience in clinical research.
  • At least 3 years of fullscope Study Startup experience​

  • Additional Information

    Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

    For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.