Clinical Operations Program Manager - Basel, Schweiz - Novartis
Beschreibung
100,000+ That's how many patients participate in our clinical trials at any given time.
GCO is Novartis' powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments.
GCO
The Clinical Operations Program Manager (COPM) is responsible for provide operational support for clinical development programs and trials where there are early viability, feasibility, allocation and site selection activities to deliver.
This role supports Clinical Operations Program Director or Associate Director (COP(a)D) for the assigned feasibility assessments and allocation strategies of trial(s).
Scope of activities include early viability, feasibility assessment, validation and refinement of allocation strategy, including scenario planning and risk management, and any re-feasibility assessments, as applicable.
Assist in analysis of external and internal data to validate and refine strategic allocation of assigned trials, aligned with program allocation strategy, thereby enabling accurate overall decision making.
Helps to develop evidence-based scenario planning to drive realistic project timelines.The COPM is accountable for the oversight, coordination and development of early viability assessments, global feasibility assessments (pre-IMB and trial feasibility), recruitment projections and allocation strategies for the assigned trials and programs.
The COPM navigates in a matrix environment and adjusts quickly to business needs.
Is a partner to the Feasibility Managers and CRMAs to ensure overall quality and delivery of feasibility assessments from initial site identification until final site allocation.
Your key responsibilities:
- Supports the COP(a)
GCO sub-team to conduct the end-to-end feasibility process starting from early viability assessments as well as pre-IMB and trial feasibilities and for developing strategic allocation, site selection and recruitment plans scenarios for the assigned programs and trials, in particular by providing:
a. Preparation and coordination of briefing information, training resources and other materials
- Coordinate and manage the editing, technical support resolution and distribution of information gathering questionnaire for feasibility at trial level between sites, countries and global. Ensure feedback from feasibility assessment is addressed
- Partners closely with the country feasibility team to align on the endtoend quality of feasibility product
- May contribute to the Operational Execution Plan:
b) Elaborates scenarios of geographic country footprint and proposed sites for participation in a clinical trial and supports COP(a)D, COPH a
GCO sub-team on final site allocation.
GCO sub-team
d) Contributes to the development of risk management strategies for clinical trial(s) highlighting feasibility-related operational risks and mitigation actions for program and trial feasibility and allocation.
- Supports the creation and maintenance of patient enrolment forecast, at study levels
Based on prior experience and analytics, works with COP(a)D to define the patient enrolment scenario that can be flexible based on the study objectives or meet specific study requirements (i.e., enrolment objectives, endpoints, cost, timelines, TPP).
b. Curates and analyses relevant data to define a projected patient rate of recruitment and the enrolment timeline, that factors in site activation roll-out for a clinical studyc.
Maintains the patient enrolment forecast from a strategic perspective and contributes to re-forecasts of patient enrolment models to adjust for new influence factors (i.e., change in drug landscape, protocol amendment, increased screen failure rate, delayed timelines, etc.).
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