Clinical Operations Program Manager

vor 3 Wochen

Basel, Schweiz Novartis Vollzeit

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. Every day, we are the link between science and medicine - imagine the impact you could have as a Clinical Operations Program Manager
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)D or the 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 end-to-end quality of feasibility product
- May contribute to the Operational Execution Plan:
a) Collection and analysis of internal and external data (i.e. local treatment standard of care, available treatment options approved/reimbursed, local prevalence and access to targeted populations) through analysis of clinical intelligence data describing the indication landscape including scientific and epidemiology data, competitive intelligence, treatment paradigms and potential site partners globally, from external and internal research data sources including analysis of historical data related to site performance (data quality, start-up cycle time, patient enrolment), based on the clinical intelligence package received from the Health Insights Manager and other data sources
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.
c) Contributes to the execution of the feasibility process by developing feasibility assessment/survey, coordinates execution of feasibility at country level, evaluates prospective sites on their operational and medical capability to conduct the study, and provides a thorough analysis and summary of feasibility outcome to the 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

a. 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 study
c. 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.).

**Commitment to Diversity & Inclusio

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