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.

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 support 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.

Qualifications:

• 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.