Global Clinical Study Manager
With operations in 35+ nations and ~27,000 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 one of the largest influenza vaccine companies 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!
The Clinical Study Manager is responsible for the on-time delivery of a clinical study (studies).
Responsible for clinical operational planning activities and leading study
execution. The Clinical Study Manager works closely with the Senior Global Clinical Operations Lead (Snr GCOL) on a program or leads one or more studies and may take on additional responsibilities as dictated by study size and complexity. The GCOL participates in or may lead the study execution team (SET), oversees study level outsourcing, and takes preventive/corrective action(s) to address study level
This role reports to: Head, Clinical Operations, and interfaces with Snr GCOL, Lead Clinical Oversight Managers (LCOMs), Clinical Oversight Managers (COMs), Therapeutic Area Program Director and Principle/Clinical Scientists. Also interfaces with Clinical Vaccine Management (CVM), Core Project Team (Core Project Manager), Regulatory, and Clinical Quality Assurance
- Clinical project management of a clinical study
- Create and drive study level timeline
- Develop overall feasibility concept and enrolment plan with input from COMs
- Develop and manage study budget
- Provide input on operational aspects of the protocol
- Ensure regulatory compliance and GCP compliance
- Responsible for oversight of TMF with periodic audits
- Responsible for/contribute to vendor selection and management including issue escalation
- Develop and manage Study Management plan and all associated documents (i.e. vendor oversight plan)
- Collaborate with CS&L team to plan and coordinate 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 COMs
- Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and COMs
- Assigns and documents study specific roles and responsibilities to internal and external team members
- Consult with COMs 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
- Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations
- Ensure standard processes, tools and procedures are used consistently for study execution
Qualifications, Skills and Experience:
- Bachelor’s 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.
- Experience in scientific/medical research.
- Specialist knowledge (e.g. vaccine and/or influenza).
- 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 process.
- Experience in overseeing global clinical trials (pharmaceutical or research institute).
- 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.
- Experience of working in a fast-paced team environment.
- Experienced in working within a Matrix Environment
- Excellent interpersonal and decision-making skills.
- Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives.
- 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.