Associate Director, Study Start Up (0.5 FTE)

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as an Associate Director, Study Start Up - home based in Australia.

This is a part-time role working 0.5 FTE. 

About this role

As part of our Ophthalmology team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Associate Director Study Start Up manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols. Identifies and leads process improvement efforts. Analyzes processes and develops strategies to increase efficiency. Participates in business development as subject matter expert in Study Start Up function.

The Associate Director Study Start Up will function operationally as a member of a Project Team being responsible of startup activities according to company policies, SOPs and regulatory requirements in addition to financial and contractual obligations. As part of the job function you will perform activities associated with feasibility and site identification, study site initiation process, interact with Ethics Committees or
deal with investigator contracts.

Key Responsibilities: 

• Performs the startup activities of assigned studies within a country or region ensuring that those are performed on-time, within the scope and in compliance with ICH/GCP guidelines, SOPs and protocol requirements.
• Collect, review, approve process and track regulatory & investigator documents required for study site activation.
• Prepare and complete regulatory process (IEC/IRBs) including ask for requirements to the EC/IRBSs, prepare and collecting specific documentation, submission and amendments, regulatory fees.
• Collaborate with Regulatory department regarding HA/CA submission/notification.
• Main responsible of ensuring the quality control of documentation included in any submission/notification.
• Adapt Informed Consent documents according to local law and document the process following guidelines and SOPs.
• Ensure contracts are fully executed, regulatory documents and approvals are granted, IP
• Release authorized and specific project deliverables are completed.
• Participate on site evaluation and feasibility process for assigned projects.
• Review and provide feedback to management on site performance related to start up activities.
• Ensures all start up information & requirements are kept up to date in the central repository for project teams Maintains up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation

Qualifications: 

• Bachelor’s Degree preferred
• Good knowledge of GCP/ICH guidelines
• Good Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards
• Minimum 5 years of relevant clinical experience
• Previous experience with investigator start-up documents and investigative sites is preferred
• Good written and communication skills
• Good organizational skills and experience working with cross functional teams
• Strong software and computer skills
• Capable of multi-tasking and working well under pressure to meet deadline coupled with a good understanding of working in a team environment
• Travel within this position is limited

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the 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

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.