Manager, Feasibility
vor 5 Monaten
Summary:
The Manager, Feasibility & Recruitment Strategy within the Clinical Development Operation; Global Feasibility and Start-up group is responsible for feasibility mobilization, country and site feasibility as well as enrollment planning activities in support of the Clinical studies. This position will oversee the framework for ensuring study planning and feasibility standards and processes and KPI’s are met or exceeded. The position is responsible for supporting the Clinical Portfolio Execution teams in order to drive rapid, accurate and robust assessments of program and protocol feasibility, as well as the timing of key start-up and recruitment milestones. Focus will be on data driven estimates, benchmarking assumptions, robust scenario development & accurate planning that are required for the delivery of clinical trials.
- Responsibilities:
- Oversee the feasibility mobilization process. Establish, implement and manage standards and processes for initiating study planning and feasibility activities, including build of data driven study assumptions from protocol go through feasibility completion.
- Support of the feasibility process. Maintain continuity across studies by documenting changes from early estimates, early feasibility, detailed assumptions, detailed feasibility, to recruitment and start up planning.
- Partner with Clinical Operations management to implement processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility at both the country and site level, as well as the timing of key recruitment milestones. Involve relevant stakeholders in the feasibility process to ensure all needs are considered and realistic study enrollment plans are developed and in place.
- Oversee and drive accurate enrollment planning. Support Clinical Operations early in the development cycle, provide initial enrollment timelines, high level budget (as applicable), potential country footprint and develop key assumptions. Ensure effective scenario generation & planning, comparing CSL’s past performance data and proposed scenarios from Industry or vendor data.
- Ensure that study teams receive timely enrollment status reports, including updated projections of enrollment completion based on actual performance. Will oversee and maintain the use of feasibility systems and tools for planning, executing and reporting enrolment scenarios and feasibility data
- Liaise with study teams to facilitate knowledge and use of study start-up tools, processes and strategies to reduce start-up time and standardize procedures. Enable achievement of activation for trials; manage at a detailed level when required and resolve problems / escalate issues as appropriate.
- Uphold and promote the Company’s reputation externally by demonstrating high professional standards and integrity in all external contacts. Maintain up to date knowledge of the Study Operations landscape, industry best practices and regulatory considerations.
- Lead, manage and develop direct reports as applicable
Qualifications:
- A minimum undergraduate degree in business, life science, pharmacy, 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)
Minimum of 5 years’ relevant clinical research (or related) experience within the pharmaceutical industry.
A solid understanding of the drug development process; a thorough understanding of the
processes associated with Feasibility, clinical study start-up and business operations.
Thorough knowledge of ICH GCP and its applicability to all stages of the clinical development process.
Well-developed strategic planning, observation and analytical operational execution
Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
Involvement in cross-functional, multicultural and international teams.
Demonstrated ability to handle complex decisions.
The following are considered desirable:
Postgraduate qualifications.
Demonstrated proficiency in advanced MS Project.
Experience in overseeing Global Clinical Trials (pharmaceutical or research institute).
**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about D
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