Regulatory Start-Up Manager, Senior Manager

• Lead and coordinate study start-up activities from protocol finalisation through site activation
• Prepare, submit, track, and maintain CTN and CTA applications and associated regulatory documentation
• Prepare and coordinate HREC submissions, amendments, annual reports, safety reports, protocol deviations, and study closure notifications
• Prepare and coordinate SSA, RGO, and governance submissions for Australian study sites
• Support Medsafe notifications and HDEC submissions for New Zealand clinical trials
• Prepare, submit, maintain, and update ANZCTR registrations throughout the study lifecycle
• Coordinate site feasibility activities and support site identification and selection
• Collect, review, and maintain essential regulatory and study start-up documentation
• Develop and maintain study-specific start-up plans, trackers, timelines, and activation strategies
• Track ethics approvals, governance approvals, contracts, budgets, and site activation milestones
• Identify, document, and elevate start-up risks and delays
• Liaise with HRECs, governance offices, regulatory authorities, investigators, study coordinators, and site administrators
• Support preparation, review, negotiation, tracking, and execution of CTRAs, confidentiality agreements, indemnities, site agreements, and other study-related contracts
• Coordinate with legal, finance, investigators, governance offices, and internal stakeholders to facilitate contract execution
• Support development, review, and negotiation of site budgets with Clinical Operations and Finance
• Maintain contract and budget trackers and provide regular study-team updates
• Ensure contractual and regulatory documentation is complete, accurate, and maintained according to company procedures and TMF/eTMF requirements
• Support onboarding and coordination of study-start-up vendors
• Participate in study team meetings and report regulatory, governance, contract, budget, and activation status
• Support internal audits, sponsor audits, inspections, and quality assurance activities
• Maintain inspection-ready documentation and contribute to quality and compliance initiatives
• Contribute to improving study start-up processes, SOPs, templates, trackers, and work instructions
• Review and QC all submissions
• Archive all submissions
• Update study document trackers

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Health Sciences, or a related discipline
• Full legal working rights in Australia are required
• Minimum 3–5 years' experience in Clinical Research, Regulatory Affairs, Study Start-Up, Clinical Operations, or a related clinical research role
• Demonstrated experience preparing and coordinating CTN and/or CTA submissions
• Demonstrated experience preparing and coordinating HREC, SSA, and RGO submissions
• Experience maintaining and updating ANZCTR registrations
• Experience supporting site activation activities from feasibility through site initiation
• Experience supporting Clinical Trial Research Agreements (CTRAs), confidentiality agreements, indemnities, site agreements, and site budget negotiations
• Experience working with investigators, study coordinators, ethics committees, governance offices, sponsors, CROs, and vendors
• Strong working knowledge of ICH-GCP and Australian clinical trial regulations
• Familiarity with Medsafe and HDEC requirements for New Zealand clinical trials is highly desirable
• Experience within oncology, metabolic, obesity, rare disease, or early-phase clinical trials is advantageous
• Strong understanding of Australian and New Zealand clinical trial regulations and requirements
• Working knowledge of Therapeutic Goods Administration (TGA), CTN and CTA Schemes, NHMRC National Statement, HREC requirements, SSA and RGO processes, ANZCTR, Medsafe clinical trial requirements, HDEC requirements, and Medicines Australia CTRA framework
• Strong project coordination and organisational skills
• Excellent attention to detail and documentation management skills
• Strong written and verbal communication skills
• Ability to manage multiple studies and competing priorities simultaneously
• Strong stakeholder management and relationship-building skills
• Ability to identify, assess, and proactively mitigate risks
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Experience using CTMS, eTMF, regulatory tracking systems, and other clinical trial management tools
• Ability to work collaboratively within cross-functional teams and external stakeholder groups

Core Competencies

Demonstrates expertise in Clinical Research and Regulatory Affairs, with a strong focus on study start-up activities, including CTN and CTA submissions, ethics approvals, and site activation processes. Proficient in managing regulatory documentation and compliance within Australian and New Zealand clinical trial frameworks.

Highest-signal resume keywords

• Clinical Research Experience
• Regulatory Affairs Knowledge
• CTN and CTA Submission Coordination
• Project Coordination Skills
• Stakeholder Management

Hard Skills

• Clinical Trial Management
• Regulatory Documentation Preparation
• Study Start-Up Coordination
• ANZCTR Registration Maintenance
• Budget Negotiation
• Risk Assessment and Mitigation
• ICH-GCP Compliance
• Contract Management
• Site Activation Support
• Documentation Management

Soft Skills

• Attention to Detail
• Written and Verbal Communication
• Organizational Skills
• Relationship-Building
• Ability to Manage Competing Priorities

Industry Keywords

• Clinical Trials
• Regulatory Affairs
• HREC Submissions
• Medsafe Requirements
• TGA Regulations
• Oncology Trials
• Early-Phase Clinical Trials
• Confidentiality Agreements
• Study Start-Up Processes
• Clinical Operations

Tools & Technologies

• Microsoft Office Suite
• CTMS
• ETMF
• Regulatory Tracking Systems