Clinical Safety Manager, CRO

Your life’s best work!

GenesisCare is now recruiting for a Clinical Safety Manager in our Clinical Research Organisation (CRO) Team. This role will operate in a lead capacity ensuring ownership and accountability for all safety reporting activities for assigned clinical trial projects.

Critical to this role is your ability to handle overall responsibility of Serious Adverse Events (SAEs)/SADEs (Serious Adverse Device Effects) in clinical trials and to ensure collection, assessment and data-entry into the appropriate safety database in accordance with SOPs, ICH GCP and applicable regulatory requirements.

On offer is a full-time permanent opportunity where you can be located in either Sydney, Melbourne, Brisbane or Adelaide. Flexible work arrangements – work from home.

More specifically you will:

• Responsible for drafting and implementing Safety Management Plans as part of clinical research projects plans coordinated by the Clinical Project Manager.
• Contribute to functional Risk Management Assessments for clinical trials led by the Clinical Project Manager.

• Monitor multiple points of Safety information communication including email, electronic data capture systems for all communication, then assimilate information based on defined workflow.
• Processing and managing SAEs/SADEs case reports arising from investigational products and/or marketed products.
• Receipt of SUSAR, SAE, review & data-entry into the appropriate safety database in accordance with SOPs, ICH GCP and applicable regulatory requirements and distribution to regulatory authorities.
• Perform quality review of SAE reports which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
• Other activities relating to case processing as appropriate per case, including but not limited to single case & end-of-study unblinding, SAE/AE reconciliation and review protocol updates for accuracy.
• Review and approval of processed cases, AE/SAE and ADE/USADE reconciliation and safety coding.
• Responsible for submission of SAE reports, periodic reports, line listings and applicable safety information to Human Research Ethics Committees (HREC), Institutional Review Board (IRB), regulatory authorities and study sponsors.
• In collaboration with Data Management, reconcile SAEs between clinical and safety databases.
• Support Clinical Project Managers in providing training to CRO staff and site staff on safety reporting.
• Responsible for managing internal CRO Safety budget and also ensuring safety services to Sponsors are delivered to scope and budget.
• Responsible for the currency of Safety SOPs, Work Instructions and templates pursuant to applicable regulatory requirements and ICH GCP.
• Initiate and lead internal safety process improvements and contribute to cross-functional process improvement endeavours.
• Maintain currency with updates to regulations, directives and guidelines concerning safety reporting requirements in clinical research.
• Support internal and external audits.

We’re interested in hearing from people who have:

• Tertiary qualifications in a science or health-related field.
• 7+ years’ minimum experience supporting clinical research / regulatory and at least 4 of these 7 years in clinical safety management in a pharmaceutical/biotech/CRO environment.
• Must have experience with managing Safety Databases.
• Experience in the oncology therapeutic area is preferred.
• Understanding of ICH-GCP and other regulatory requirements.
• Experience with common project management methodologies.
• Ability to write, collate and present reports.

Benefits of joining our team:

• Working with a vibrant team aligned with providing the best patient experience possible and outcomes.
• Internal and external training and development opportunities.
• Close knit internal community.
• All employees and their family members have access to free confidential support that is completely external to GenesisCare including financial, nutritional and wellbeing coaching, legal advice & counselling.
• Enhance your holistic wellbeing with our Full Circle wellbeing program.
• Learn and grow with our award-winning development programs.
• Free access to thousands of LinkedIn training courses.
• Range of benefits available: Qantas membership discount, gym membership discount, 12 weeks paid parental leave, Bupa discount.

About GenesisCare

We are 1,300+ highly trained healthcare professionals and support staff in Australia designing innovative treatments and care for people with cancer. Our dedicated teams treat more than 30,000 patients annually.

People centricity is at the heart of what we do whether that person is a patient, a referring doctor, a partner or someone in our team. We aim to build culture of care that is patient focused and performance driven. Our people promise is "do your life's best work, by always growing, having a profound human impact and making great things happen together." If you'd like to make a difference, join us at GenesisCare.