Global Study Start-Up Lead (Remote)

Rho; Polska; Remote; PLN 395,000 - 527,000; Full time

Job summary

Rho is a data-driven CRO looking for a Study Start Up Lead willing to be located in Italy, Spain, Poland, Latvia, Lithuania or Bulgaria. This remote role emphasizes global startup activities, regulatory submissions, and cross-functional collaboration across SSU teams to drive timely site activations.

You will partner with Project Managers and Clinical Trial Leads, overseeing SSU associates, managing IRB/EC submissions, and coordinating SIV/activation plans across regions.

Qualifications

• At least 4 years of industry experience, including 2+ years of study start up leading experience or equivalent.
• Demonstrated ability in the leadership of a team of individuals in study start-up.
• Knowledge of applicable international regulatory requirements and guidelines (ICH-GCP, EU-Directives).
• Strong knowledge of Regulatory and Central/Local ethics submission processes for assigned countries.
• Strategic and creative risk management and contingency planning.
• Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members.
• Excellent organizational and interpersonal skills.
• Global start up experience is preferred.
• Proficient computer and internet skills, including working knowledge of MS-office applications, such as MS Outlook, Word and Excel.
• Expected required travel 10% on average.

Responsibilities

• Manage the study start up process through site activation, working with Project Manager and Clinical Trial Lead to ensure timely site activations
• Participate in Sponsor meetings with respect to study start up, including endorsement of the SSU Operational Targets & mitigation of delivery risks, establishing client expectations for delivery, communication, reporting, and metrics
• Partner closely with both Functional Leads and SSU Team Members to proactively identify study start up related issues
• Ensure that relevant systems are maintained and up to date to analyze study start-up progress metrics against targets/timelines (at a project/country/site level)
• Provide operational oversight to SSU Associates on assigned projects
• Responsible for all submissions and obtaining approval from IRB/ECs (incl CTIS Part 2 package);
• May be responsible for submissions to Regulatory Authorities in non-EU countries (ex UK, Georgia, South Africa etc)
• Coordinate feasibility efforts and work together with Clinical Team Leads on site identification
• Identify the Site Essential Document (SED) packet elements required, agree with relevant internal staff, track the completion and upload of documents, and communicate with all parties (e.g., Sponsor, Site Staff, Internal Staff) the status of documents; participate as the SED Reviewer as necessary
• Coordinate and develop the Start Up approach for IRB/EC approval at specified regional levels, including country level approval, and provide oversight of specific activities from SSU Team Members
• Partner with Clinical Team Leads and the client to identify requirements for the Site Initiation Visit (SIV) and Site Activation
• Coordinate the informed consent form (ICF) development, including the review, negotiation and approval with relevant internal and external parties
• Support business development with proposal preparation and review and bid defense efforts
• Coordinate site budget development, including the review, negotiation and approval with relevant internal and external parties.
• Coordinate site contract negotiation process
• Develop country/site-specific startup timelines and strategies and oversee startup activities in the country
• Facilitate cooperation between cross-functional teams regarding startup activities

Skills

Leadership

Communication

Organizational skills

Interpersonal skills

Strategic thinking

Problem solving

Presentation skills

MS Office

Job description

Rho is a data-driven CRO looking for a Study Start Up Lead willing to be located in Italy, Spain, Poland, Latvia, Lithuania or Bulgaria. This remote role emphasizes global startup activities, regulatory submissions, and cross-functional collaboration across SSU teams to drive timely site activations.

You will partner with Project Managers and Clinical Trial Leads, overseeing SSU associates, managing IRB/EC submissions, and coordinating SIV/activation plans across regions.