|Job Type:||Full Time|
With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
We have an opportunity for an Early Development Senior Study Manager/Study Manager. The Senior Study Manager/Study Manager is responsible for/supports the on-time delivery of Early Development clinical studies, clinical operational planning activities and leading/supporting study execution of early stage clinical studies. Working closely with the Director of Early Development, Global Clinical Operations and Clinical Program Manager (CPM) the incumbent in this position will lead/support one or more studies, lead/participate in the Study Execution Team (SET), oversees study level outsourcing and take preventive/corrective action(s) to address study level issues.
Key responsibilities to ensure study delivery include:
- Clinical project management of an ED clinical study
- Create and drive study level timeline
- Develop overall feasibility concept and enrolment plan with appropriate input from internal stakeholders
- Develop and manage study budget
- Provide input on operational aspects of the protocol
- Ensure regulatory compliance and Good Clinical Practice GCP compliance
- Responsible for oversight of Trial Master File TMF with periodic audits
- Responsible for/contribute to vendor selection and ongoing management and oversight of all outsourced activities
- Collaborate with vendors and internal stakeholders to ensure that data is available for review by the Safety Review Committee in a timely manner
- Collaborate with Clinical Trial & Logistics team to plan and coordinate Investigational Medicinal Product (IMP) and non-IMP supplies
- Ensure monitoring plan is developed and consistently executed in collaboration with appropriate stakeholders
- Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and internal stakeholders
- Assigns and documents study specific roles and responsibilities to internal and external team members
- Ensure Clinical Operations team and external partner receive study specific training
- Report key study performance information, including study start-up metrics, enrolment, data collection timeliness/quality
- Facilitate study close out activities through completion of Clinical Study Report
To be successful
Minimum of Bachelor Degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred. Other degrees and certifications considered if commensurate with related clinical research experience (e.g. diploma or associate degree RN, certified medical technologist).
- A minimum 5 years' relevant clinical research (or related) experience within the pharmaceutical industry.
- A solid understanding of the drug development process, and specifically, each step within the clinical trial
- Early Phase Clinical studies
- Experience in overseeing global clinical trials (pharmaceutical or research institute).
- Budget forecasting and management.
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development
- Ability to work independently with some oversight in the support and/or management of clinical trial execution.
Applications close 15th March, 2020
Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, Australian working rights and other relevant checks form part of the candidate suitability evaluation