Job Title

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 Provider (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 roleAs part of our Ophthalmology team, you will work 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 a subject matter expert in Study Start Up function.The Associate Director Study Start Up will function operationally as a member of a Project Team, responsible for startup activities according to company policies, SOPs, and regulatory requirements, in addition to financial and contractual obligations. Activities include feasibility studies, site identification, study site initiation, interaction with Ethics Committees, and handling investigator contracts.Key Responsibilities:Performs startup activities of assigned studies within a country or region, ensuring they are completed on time, within scope, and in compliance with ICH/GCP guidelines, SOPs, and protocol requirements.Collects, reviews, approves, processes, and tracks regulatory and investigator documents required for study site activation.Prepares and completes regulatory processes (IEC/IRBs), including requesting requirements from EC/IRBs, preparing and collecting documentation, submissions, amendments, and managing regulatory fees.Collaborates with Regulatory department regarding Health Authority (HA) and Competent Authority (CA) submissions and notifications.Ensures quality control of documentation included in submissions and notifications.Adapts Informed Consent documents according to local laws and documents the process following guidelines and SOPs.Ensures contracts are fully executed, regulatory documents and approvals are obtained, and intellectual property rights are protected.Completes authorized and specific project deliverables.Participates in site evaluations and feasibility assessments for assigned projects.Reviews and provides feedback on site performance related to startup activities.Keeps all startup information and requirements up to date in the central repository for project teams, maintaining adherence and compliance with local regulations.Qualifications:Bachelors Degree preferred.Good knowledge of GCP/ICH guidelines.Good knowledge of applicable regulatory requirements, SOPs, and company standards.Minimum 5 years of relevant clinical experience.Experience with investigator startup documents and investigative sites is preferred.Strong written and communication skills.Good organizational skills and experience working with cross-functional teams.Proficient in relevant software and computer skills.Ability to multitask and work well under pressure to meet deadlines, with a good understanding of teamwork.Limited travel required.What We OfferWe offer a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment. Join a team that values collaboration, innovation, and making a difference in patients lives.About UsFounded over 27 years ago in Lund, Sweden, TFS HealthScience is a full-service, global CRO with over 800 professionals delivering tailored clinical research services across more than 40 countries. We focus on therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.Our core valuesTrust, Quality, Passion, Flexibility, and Sustainabilityguide our decision-making and culture. We strive to attract and retain talented individuals who share these values, fostering a culture of innovation, excellence, mutual respect, and collaboration. Together we make a difference. #J-18808-Ljbffr