Study Start Up Associate

This role will focus on ensuring compliance, effective communication, and timely completion of start-up deliverables for clinical trials.

Considered candidates will have at least 2 years of experience in clinical trial start-up, strong organizational and communication skills, and the flexibility to take on diverse responsibilities.

• Support the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives
•  Generate and provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools
•  Proactively identify and escalate issues that arise related to support SSU deliverables
•  Effectively execute against assigned activities within SSU
•  Support implementation of standards for global SSU team
•  Oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other site activation requirements
• Implementation of the SSU Strategy for assigned region during the study start up period
• Building relationships with internal counterparts and site staff to support successful site activation strategies
• Projecting site activation timelines and appropriately escalating when things get off track
• Adhering to process and tools designed to the support of the SSU team with day-to-day activities
• Leading the preparation of study level essential document templates
• Aiding in the preparation of content for Regulatory submissions
• Handling ICF negotiations and facilitating any required escalations
• Preparation and submission of IMP Release Packages
• Maintaining accurate and timely information in relevant clinical systems
• Responsible for complying with regulations and guidelines and ensuring adherence in support of assigned clinical trials

• Experience: minimum 2 years in clinical trial start-up, including regulatory experience and exposure to SSU processes, ICF creation, and site activation
• Soft skills: strong communication, organizational skills, and ability to build and maintain site relationships
• Flexibility: willingness to work in a dynamic, evolving environment and handle diverse responsibilities
• Language proficiency: fluent in English and French to facilitate communication and site engagement

#LI-KD1