The Site Activation Manager I plays a key role in managing and leading Site Start-Up (SSU) deliverables for clinical trials within Mexico, operating in a home-based capacity. This position ensures timely site activation and regulatory adherence while supporting sponsor-dedicated projects throughout the trial lifecycle.
Key Responsibilities
- Manages assigned SSU project tasks from initiation through lifecycle maintenance, ensuring alignment with project goals and timelines.
- Leads the planning and execution of SSU activities, including development of timelines, risk assessment, and progress reporting to project stakeholders.
- Coordinates with cross-functional teams such as Clinical Operations, Regulatory, Contracts, and Project Management to streamline start-up processes.
- Oversees regulatory submissions, including amendments, import/export licenses, and communications with ethics committees and health authorities.
- Ensures execution of clinical trial agreements and investigator budgets are delivered and maintained.
- Reviews and prepares core regulatory documents, performs regulatory impact assessments, and supports updates to informed consent materials.
- Monitors project timelines and adjusts plans as needed due to protocol amendments or evolving sponsor requirements.
- Ensures compliance with Standard Operating Procedures and sponsor-specific processes, maintaining accurate documentation for audit readiness.
- Tracks project performance against budget and milestones, identifying deviations and implementing corrective actions when necessary.
- Contributes to departmental improvements and supports change initiatives within the SSU function.
- Ensures all essential documents are submitted to the Trial Master File in accordance with company and sponsor standards.
Qualifications
A Bachelor’s degree is required, along with a solid understanding of clinical trial operations across Phases II–IV and ICH GCP guidelines. Candidates must demonstrate experience in project management within fast-paced environments, strong organizational and communication abilities, and a commitment to quality and compliance. Familiarity with vendor oversight and regulatory processes is essential. A higher degree is preferred.
Work Environment
This role operates in a home-based setting within Mexico, with minimal travel required (up to 25%). The position supports a flexible, inclusive work culture focused on collaboration, innovation, and professional growth.
