Job Description

Turn study plans into active clinical trial sites, and help bring recent medicines closer to patients.

We’re looking for a proactive Country Study Start Up Specialist to take ownership of the critical activities that move clinical studies from planning through to site activation in Australia.

Working across studies and sites, you’ll be at the centre of the start-up process, coordinating ethics submissions, essential documentation, informed consent materials and site activation requirements while partnering with Clinical Operations, Regulatory Affairs, Contracts, CRAs and regional and global Study Start Up teams. You’ll anticipate roadblocks, bring the right people together and help keep studies progressing on time and to a high standard.

This is an opportunity for someone with clinical research, study start-up, site activation or regulatory submissions experience who enjoys solving problems, managing competing priorities and seeing their work translate into sites becoming ready to enrol patients.

KEY DUTIES AND RESPONSIBILITIES

- Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope primarily central IRB/EC sites. Establish the
- country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs.
- Proactively identify and communicate issues impacting delivery and providing proposed solutions
- Attend regional/area start up calls and providing input for assigned sites/studies.



Collection of essential documents from sites and completing quality check (ALCOA).
- Compile and submit ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting. Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements.
- Collaborate with contract manager, CRA, Area CSM Lead as required to assure timely site activation.
- Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas. Trigger clinical supply shipments.
- Complete IP release activities and triggering IP shipment.
- Issue site green light letter and activating sites in IXRS. Track all start up and maintenance related activities in Vault SSU as appropriate. Maintain local country and site intelligence database and EDLs in Vault.
- Maintain SSU performance metrics and KPIs for assigned sites/studies. Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads. Ensure audit/inspection readiness.
- Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
- Participate in process improvement initiatives as required.
- Report any adverse event within 24 hours as per AbbVie’s policies and procedures.
- Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times.
- Adhere to AbbVie’s codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
- Other ad hoc duties such as administrative duties, as requested.

📌 Country Study Start Up Specialist (Sydney)
🏢 Abbvie
📍 Sydney