Regulatory Start-Up Manager, Senior Manager

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

📋 Description

• Oversee and manage study start-up processes from the finalization of the protocol to site activation.

• Prepare, submit, track, and maintain Clinical Trial Notification (CTN) and Clinical Trial Agreement (CTA) applications along with relevant regulatory documentation.

• Prepare and coordinate submissions to Human Research Ethics Committees (HREC), including amendments, annual reports, safety reports, protocol deviations, and notifications for study closures.

• Prepare and manage Site Specific Approvals (SSA), Research Governance Office (RGO), and governance submissions for research sites in Australia.

• Assist with Medsafe notifications and submissions to the Health and Disability Ethics Committee (HDEC) for clinical trials in New Zealand.

• Prepare, submit, maintain, and update Australian New Zealand Clinical Trials Registry (ANZCTR) registrations throughout the duration of the study.

• Coordinate site feasibility assessments and assist with site identification and selection processes.

• Collect, review, and ensure the maintenance of essential regulatory and study start-up documentation.

• Develop and uphold study-specific start-up plans, trackers, timelines, and activation strategies.

• Monitor ethics approvals, governance approvals, contracts, budgets, and milestones related to site activation.

• Identify, document, and escalate any risks and delays associated with the start-up process.

• Communicate effectively with HRECs, governance offices, regulatory authorities, investigators, study coordinators, and site administrators.

• Assist in the preparation, review, negotiation, tracking, and execution of Clinical Trial Research Agreements (CTRAs), confidentiality agreements, indemnities, site agreements, and other contracts related to the study.

• Collaborate with legal, finance, investigators, governance offices, and internal stakeholders to streamline contract execution.

• Support the development, review, and negotiation of site budgets in partnership with Clinical Operations and Finance.

• Maintain contract and budget trackers, providing regular updates to the study team.

• Ensure that all contractual and regulatory documentation is complete, accurate, and maintained in accordance with company procedures and Trial Master File (TMF)/electronic TMF (eTMF) requirements.

• Assist in the onboarding and coordination of study start-up vendors.

• Participate in study team meetings, reporting on regulatory, governance, contract, budget, and activation statuses.

• Support internal audits, sponsor audits, inspections, and quality assurance activities.

• Maintain documentation that is inspection-ready and contribute to initiatives focused on quality and compliance.

• Contribute to the enhancement of study start-up processes, standard operating procedures (SOPs), templates, trackers, and work instructions.

• Review and ensure quality control for all submissions.

• Archive all submissions appropriately.

• Update trackers for study documentation.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Nursing, Pharmacy, Health Sciences, or a related field is required.

• Full legal working rights in Australia are mandatory.

• A minimum of 3–5 years of experience in Clinical Research, Regulatory Affairs, Study Start-Up, Clinical Operations, or a similar role within clinical research.

• Proven experience in preparing and coordinating CTN and/or CTA submissions.

• Demonstrated ability to prepare and coordinate HREC, SSA, and RGO submissions.

• Experience in maintaining and updating ANZCTR registrations is essential.

• Familiarity with site activation processes from feasibility assessments to site initiation is required.

• Proven experience in supporting Clinical Trial Research Agreements (CTRAs), confidentiality agreements, indemnities, site agreements, and site budget negotiations.

• Experience collaborating with investigators, study coordinators, ethics committees, governance offices, sponsors, Contract Research Organizations (CROs), and vendors.

• Strong understanding of ICH-GCP and Australian clinical trial regulations is necessary.

• Familiarity with Medsafe and HDEC requirements for New Zealand clinical trials is highly desirable.

• Experience in oncology, metabolic disorders, obesity, rare diseases, or early-phase clinical trials is an advantage.

• A comprehensive understanding of clinical trial regulations and requirements in Australia and New Zealand is crucial.

• Proficient 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 organizational capabilities are required.

• Exceptional attention to detail and documentation management skills are essential.

• Excellent written and verbal communication skills are necessary.

• Ability to manage multiple studies and competing priorities effectively is required.

• Strong stakeholder management and relationship-building abilities are essential.

• Capability to identify, assess, and proactively mitigate risks is a must.

• Proficiency in the Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) is required.

• Experience with Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), regulatory tracking systems, and other clinical trial management tools is beneficial.

• Ability to collaborate effectively within cross-functional teams and with external stakeholder groups is necessary.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Opportunities for professional development and career advancement.

• Supportive and collaborative work environment.

• Flexible working arrangements.

• Access to comprehensive health and wellness programs.