Senior Site Start up Associate

11 Premier Research International LLC; Argentina; Presencial; ARS 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Premier Research is seeking a Senior Site Start up Associate to join our Clinical Monitoring, Site Management and SSU team. You will help transform ideas and drive start-up activities across biotech, medtech, and pharma projects, enabling timely trials and patient access.

This role requires strong regulatory knowledge, English communication, and a collaborative mindset to coordinate with Project Managers, Regulatory Start-up Leads, and local authorities.

Formación

• Bachelor's degree or international equivalent in a clinical, science, or health-related field.
• 5+ years of direct start up experience.
• Thorough knowledge of FDA Guidance Documents / EU Directives / Local Regulations / ISO14155.
• Knowledge of country-specific regulatory requirements for clinical trials.
• Excellent teamwork and cross-functional collaboration.
• Strong verbal and written English communication skills.

Responsabilidades

• Forecasts submission/approval timelines and ensures they are adhered to.
• Provides rationale for delays, contingency plans, and escalates issues as needed.
• May serve as primary contact for PM, Clinical Lead, Regulatory Start-up Manager during start-up.
• Prepares submissions and amendments required by EC/IRB per local rules.
• Submits end of study notifications to ECs/IRBs and local authorities.
• Oversees essential document collection/review to ensure sponsor/investigator obligations meet local requirements.
• Local contract/budget negotiation for site contracts where applicable.
• Reviews informed consent templates and other patient documents for the country.
• Supports start-up strategy development at proposal stage to support business opportunities.

Conocimientos

Strong English communication

Team player

Educación

Bachelor's degree or international equivalent

Descripción del empleo

Premier Research is looking for a Senior Site Start up Associate to join our Clinical Monitoring, Site Management and SSU team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

What You'll Be Doing:

• Forecasts submission/approval timelines and ensures they are adhered to.
• Provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified.
• May serve as the primary point of contact for the Project Manager, Clinical Lead, Regulatory Start-up Manager (or designee) during start-up on allocated projects.
• Prepares ongoing submissions, amendments, required by central and local EC/IRB, as required by local rules.
• Submits end of study notifications to ECs/IRBs and other local authorities in the specified country according to national timelines.
• Performs/oversees essential document collection and review, ensuring that sponsor and investigator obligations are being met and comply with applicable local regulatory requirements and ICH/GCP guidelines.
• Local Investigator Contract and budget negotiator (where applicable) produces site-specific contracts from country template.
• Submit proposed contract and budget to the site for review.
• Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.
• Provides quality review of the informed consent and adapts the template as appropriate, as well as other patient documents, or specific documentation that is required in the country.
• May support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.

What We Are Searching For:

• Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional
• 5+ years of direct study start up experience
• Thorough knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures.
• Thorough knowledge of the relevant country specific regulatory requirements for conducting clinical trials and of site and institution specific contract requirements
• Expertise in the development and review of Informed Consent Form templates, other patient documents, or specific documentation that is required in the country.
• An excellent team player with the ability to develop and maintain strong relationships across the organization to provide awareness of future issues and promote collaboration and problem-solving.
• Strong verbal and written communication skills in English

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning. Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.