[Hiring] Study Start Up Lead @TFS HealthScience

Role Description

Join Our Team as a Study Start Up Lead in Australia (home based) - 1 FTE for next 3 months, then 0.2 FTE for additional 3 months.

As part of our CDS - Dermatology, Immunology, Internal Disease area team, you will work alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Study Start Up Lead is responsible for coordination and overview of startup activities from projects being awarded until the last participant site is activated, ensuring the startup deliverables and timelines are achieved.

The Study Start Up Lead will:

• Work in accordance with company policies, SOPs, regulatory requirements, and financial and contractual obligations.
• Plan and proactively coordinate, together with the study PM, the study startup activities to ensure key milestones are achieved and startup is performed within budget, on schedule, and in compliance with the appropriate quality standards.

Qualifications

• Bachelor’s Degree, preferably in life science or nursing; or equivalent.
• Minimum 4 years of experience in any relevant Clinical Operations experience related to Start Up procedures.
• Able to work in a fast-paced environment with changing priorities.
• Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas.
• Possess an understanding of Good Clinical Practice regulations and ICH guidelines.
• Ability to work independently as well as in a team matrix organization and on multiple projects.
• Excellent written and verbal communication skills as well as computer skills.
• Excellent organizational and Line Management skills.
• Ability and willingness to travel up to 10-20%.

Requirements

• Ensure all startup activities for projects are performed on-time, within the scope and budget, and in compliance with ICH/GCP guidelines, SOPs, and protocol requirements.
• Together with the study Project Manager, manage the strategic aspects of project startup and mitigate any risk by setting up the proper action plan.
• May oversee and coordinate SSU Specialists, assigned to their programs, being the initial point of contact and supporting them with startup activities and investigative sites liaison.
• Develop and maintain Startup plan and timelines for their projects and track progress ensuring project deliverables and milestones are reached.
• May manage the resource allocation of Start Up team on the project, in collaboration with respective line managers.
• Responsible for coordinating EC/IRB submissions or any other notification requested as well as coordination with Regulatory department regarding HA/CA submissions/notification.
• Ensure and oversee the proper adaptation of Subject Information and Informed Consent documents according to local law and requirements.
• Together with the Legal Department, coordinate the Clinical trial Agreements negotiation supporting the SSU Specialists and CRAs on handling the negotiation properly and on time.
• Coordinate site evaluation and feasibility process for assigned projects.
• Ensure all Start Up documentation is submitted properly and on time to the Trial Master File.
• Assist the Project Manager in ensuring the Project is properly set up in CTMS and all information related to startup activities is properly updated.
• Support the Project Manager in coordinating the greenlight and site activations process and ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized, and specific project deliverables are completed.
• Measure and evaluate project startup deliverables and metrics.
• Update the Project Manager with the status of startup progress and ensure a proper escalation of any issue detected.

Benefits

• We provide a competitive compensation package.
• Comprehensive benefits.
• Opportunity for personal and professional growth in a rewarding environment.
• You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.