Study Start Up Lead

Rho; Polska; Remoto; PLN 395.000 - 527.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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

Conoscenze

Leadership

Communication

Organizational skills

Interpersonal skills

Strategic thinking

Problem solving

Presentation skills

MS Office

Descrizione del lavoro

Join us in redefining what it means to work for a CRO.

When you work at Rho, it's more than just a job—you become part of the Rho Factor. We're a proud bunch of science nerds who love tackling big challenges together. We're not your typical CRO, and we're not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.

Whether you're a data wizard, analytical genius, project mastermind, or any other role, you'll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other.

You'll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.

This is your opportunity to join Rho as a Study Start Up Lead - we are open to this role being located in Italy, Spain, Poland, Latvia, Lithuania or Bulgaria. This is a remote opportunity.

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

Requirements

• 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 (i.e., ICH-GCP, and/ or EU-Directives)
• Strong knowledge of Regulatory and Central/Local ethic 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
• Strategic and tactical thinking skills
• Client-focused action-oriented approach to work
• Ability to work independently, prioritize and work with a matrix team environment is essential
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
• Strong presentation 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