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Study Start Up Lead

1 week, 1 day ago
Spain, Bulgaria, Italy, Latvia, Lithuania, Poland
Full-time
Senior
Project Manager
Project and Program Management
Apply Now
Rho

Rho

Rho is a full-service Contract Research Organization (CRO) that combines innovation and scientific rigor to maximize results in every phase of clinical research. With a global team of experts, Rho ensures consistent and efficient trials, offering compr...

Biotechnology
251-1K
Founded 1984
View All Jobs 16

Description

  • Manage the study start-up process through site activation in partnership with the Project Manager and Clinical Trial Lead.
  • Participate in sponsor meetings to set study start-up operational targets, manage delivery risks, and define communication, reporting, and metric expectations.
  • Partner with Functional Leads and SSU team members to identify and resolve study start-up issues proactively.
  • Maintain study start-up systems and metrics to track progress against targets and timelines at project, country, and site levels.
  • Provide operational oversight to SSU Associates on assigned projects.
  • Manage submissions and approvals for IRB/ECs, including CTIS Part 2 packages, and support regulatory submissions in non-EU countries when needed.
  • Coordinate feasibility activities and support site identification with Clinical Team Leads.
  • Oversee Site Essential Document packet requirements, document tracking, uploads, and status communication with sponsors, sites, and internal teams.
  • Coordinate the start-up approach for IRB/EC approval and oversee related activities performed by SSU team members.
  • Coordinate informed consent form development, site budget development, site contract negotiation, and site initiation/site activation requirements.
  • Develop country- and site-specific startup timelines and strategies and oversee startup activities in-country.
  • Support business development activities, including proposal preparation, review, and bid defense efforts.

Requirements

  • At least 4 years of industry experience, including 2+ years of study start-up leadership experience or equivalent.
  • Demonstrated ability to lead a team of individuals in study start-up.
  • Knowledge of international regulatory requirements and guidelines, such as ICH-GCP and/or EU Directives.
  • Strong knowledge of regulatory and central/local ethics submission processes for assigned countries.
  • Strategic and creative risk management and contingency planning skills.
  • Strong written and verbal communication skills for explaining complex ideas to study personnel, internal teams, and sponsors.
  • Excellent organizational, interpersonal, presentation, strategic thinking, and tactical thinking skills.
  • Ability to work independently, prioritize effectively, and operate in a matrix team environment.
  • Client-focused, action-oriented approach with a positive attitude and ability to work across all staff levels.
  • Proficiency with computer and internet tools, including MS Outlook, Word, and Excel.
  • Global start-up experience is preferred.
  • Expected travel of about 10% on average.
  • Resume/CV must be submitted in English.

Interested in this position?

Apply directly on the company website

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