Study Start Up Lead

This is a fully remote position, open to applicants in Australia.

📋 Description

• Ensure that all startup activities for projects are executed punctually, within the defined scope and budget, and in alignment with ICH/GCP guidelines, standard operating procedures (SOPs), and protocol specifications.

• Collaborate with the study Project Manager to manage the strategic elements of project startup while mitigating risks by establishing appropriate action plans.

• Supervise and coordinate SSU Specialists assigned to their programs, serving as the primary contact and providing support for startup activities and liaison with investigative sites.

• Create and maintain startup plans and timelines for projects, monitoring progress to ensure that project deliverables and milestones are achieved.

• Responsible for coordinating submissions to the Ethics Committee/Institutional Review Board (EC/IRB) or any other required notifications, as well as liaising with the Regulatory department regarding Health Authority/Competent Authority submissions and notifications.

• Ensure proper adaptation of Subject Information and Informed Consent documents according to local laws and requirements.

• Oversee the site evaluation and feasibility assessment process for assigned projects.

• Ensure that all startup documentation is accurately submitted and on time to the Trial Master File.

• Assist the Project Manager in ensuring that the project is correctly set up in the Clinical Trial Management System (CTMS), with all information related to startup activities updated appropriately.

⛳️ Requirements

• Bachelor’s Degree, preferably in life sciences or nursing, or an equivalent qualification.

• A minimum of 4 years of relevant experience in Clinical Operations specifically related to Startup procedures.

• Ability to thrive in a fast-paced environment with shifting priorities.

• Familiarity with basic medical terminology and the science associated with the assigned drugs and therapeutic areas.

• Strong understanding of Good Clinical Practice regulations and ICH guidelines.

• Capability to work autonomously as well as collaboratively within a team matrix organization and across multiple projects.

• Exceptional written and verbal communication skills, along with proficient computer skills.

• Outstanding organizational and line management abilities.

• Willingness and ability to travel up to 10-20% of the time.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional growth in a supportive environment.

• Collaboration, innovation, and the chance to make a meaningful impact in the lives of patients.