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Senior Clinical Study Manager, Early Development-CV/Metabolism
at CSL Limited
The Clinical Pharmacology and Translational Science (CPAT) Senior Clinical Study Manager (SM)/SM is responsible for/supports the on-time delivery of CPAT clinical study (studies). The CPAT Senior SM/SM is responsible for/supports clinical operational planning activities and leading/supporting study execution of early stage clinical studies. The CPAT Senior SM/SM works closely with the Director CPAT Operations or CPAT Program Manager (PM) and leads/supports one or more global studies and may take on additional program responsibilities with oversight as required. The CPAT Senior SM/SM leads/participates the Study Execution Team (SET) and oversees study level outsourcing and takes preventive/corrective action(s) to address study level issues. The CPAT Senior SM/SM may be required to co-monitor as needed.
RESPONSIBILITIES AND ACCOUNTABILITIES
Execution of operational activities to ensure clinical study delivery
Act as the primary point of contact for internal groups outside of Early Development (Research, Regulatory, Bioanalytics , and Project Management) for study specific information
Maintain up to date knowledge of the Early Stage clinical studies, product candidate(s), clinical practice, competitors, and regulatory considerations
Ensure that IMPACT data is complete in a timely manner
Ensure standard processes, tools and procedures are used consistently for study execution
Support regulatory submissions, as required
Review country/site ICF
Support audits/inspections and resolution of findings
Support IMP management
Track contract execution and assist in resolution of site contract issues as required
Co-monitor as required
Clinical Project Management of an ED clinical program/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 compliance
Responsible for oversight of Trial Master File with periodic audits
Responsible for/contribute to vendor selection and ongoing management (including issue escalation) and oversight of all outsourced activities
Develop and manage Study Management Plan and all associated documents (i.e. vendor oversight plan)
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 CS&L team to plan and coordinate Investigational Medicinal Product (IMP) and non-IMP supplies. Plan, facilitate and lead SET internal meetings as well as act as the CSL lead for vendor meetings
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
Consult with internal stakeholders for strategic selection of countries and sites
Facilitate and coordinate communications with external provider
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
At minimum, 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).
Postgraduate qualifications highly desirable.
As a guide, a minimum 6+ years’ relevant clinical research (or related) experience within the pharmaceutical industry.
Experience in overseeing global clinical trials (pharmaceutical or research institute) is required.
A solid understanding of the drug development process, and specifically, each step within the clinical trial process. Prior experience in scientific/medical research advantageous.
Experience in Early Phase Clinical studies
Budget forecasting and management.
Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
Ability to work independently with some oversight in the support and/or management of clinical trial execution.
Communication and Interpersonal
Demonstrated ability to lead teams and work in a fast-paced team environment.
Experienced in working within cross-functional team in a Matrix Environment
Excellent interpersonal and decision making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives. Negotiation and influential skills advantageous.
Excellent understanding of all tasks involved in a clinical development program from developing a protocol through finalizing a clinical study report.
Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards.
Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
Extensive and comprehensive knowledge of ICH guidelines/GCP, Maintains current medical/scientific/regulatory knowledge.
Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
Excellent written and oral communication skills.
Maintains computer literacy in appropriate software
Travel Requirements (Domestic, International, frequency)
Some degree of local, interstate and international travel required.
This is a full time position located at one of CSL’s site. A degree of remote/home working will be considered.
CSL is introducing a new Career Framework, which will provide a common, global infrastructure for managing jobs and serve as a foundation for future career development and competitive rewards. Certain components of this job description, including Title and Level are subject to change relative to applicable local laws. Your Talent Acquisition Consultant will discuss the pending changes with you.
Worker Sub Type:Regular
With operations in 35+ nations and ~ 20,000 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!
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