Clinical Safety Manager, CRO
1 month ago
At GenesisCare we want to hear from people who are as passionate as we are about innovation and working together to drive better life outcomes for patients around the world.
Job Title: Clinical Safety Manager, CRO
Location: Sydney / Melbourne / Brisbane / Adelaide
Do your life’s best work
As a Clinical Safety Manager in the GC CRO team, you will operate in a lead capacity ensuring ownership and accountability of for all safety reporting activities for assigned clinical trial projects in the CRO.
What you’ll do:
Overall responsibility of the handling 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; Activities will include but not limited to:
Monitor multiple points of Safety information communication including email, fax, 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.
Liaison with site staff and Medical Monitors as applicable to clarify appropriate information required for case processing.
Support the Medical Monitor in safety activities as required such as medical review and event descriptions.
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
Responsible for drafting and implementing Safety Management Plans as part of clinical research projects plans coordinated by the Clinical Project Manager;
In collaboration with Data Management, reconcile SAEs between clinical and safety databases;
Contribute to functional Risk Management Assessments for clinical research studies coordinated by the Clinical Project Manager;
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;
Act as a Project Lead for Safety-only projects; if applicable
Maintain currency with updates to regulations, directives and guidelines concerning safety reporting requirements in clinical research;
Support internal and external audits;
Responsible for hiring, training and all aspect of performance management of any Clinical Safety Associate; and
Maintain effective professional relationships with sponsors, external customers, investigators, vendors and the internal project team.
Who you are:
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-GCPand other regulatory requirements;
Experience with common project management methodologies;
Ability to write, collate and present reports.
What’s in it for you:
Own your development, learn every day and be part of GenesisCare CRO's rapid growth Thriving close-knit culture and communities and supportive environment with encouragement to live your highest potential A rewarding purpose-led organisation that provides positive outcomes to patients everyday Fast paced, high performing & agile working culture with lots of change due to our rapid growth 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 Learn and grow with our award-winning development programs Free access to thousands of LinkedIn training coursesWho we are:
We are 6000+ highly trained healthcare professionals and support staff across the United States, Australia, the U.K, Spain and China, designing cancer and heart disease treatments to help patients achieve the best possible life outcomes.
Global care
Across the world, we have more than 580+ centres to help us bring the right care to our patients. Every year our team sees more than 1.4 million patients globally across our Oncology, Cardiology & Sleep Medicine Centres.
People centricity is at the heart of what we do and we pride ourselves on making our people a priority, whether that be a patient or an employee. 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 truly make a difference, join us at GenesisCare
GenesisCare is an Equal Opportunity Employer.
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