79 days ago on sjobs.brassring.com

Senior Trial Operations Manager (TOM), Oncology GMO

Novartis Pharma Schweiz AG

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Senior Trial Operations Manager (TOM), Oncology GMO

Job ID193385BRPosition TitleSenior Trial Operations Manager (TOM), Oncology GMODivisionPHARMABusiness UnitONCOLOGY BU - NPHCountrySwitzerlandWork LocationBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegularJob DescriptionManage all operational aspects of clinical trials / projects for assigned compound/(s) to execute to the GPT/GMPT Objectives, including optimal trial allocation and recruitment of studies, based on patient accessibility, speed and cost. Organize input during protocol development, perform trial feasibility assessment together with the GMO organization and ensure optimum utilization of resources in cooperation with the GMO Region Heads and Regional ARMs and setting of realistic timelines together with the Clinical Team.

• Work closely with Regional ARMs, GMO Region Heads and GMO Country Heads on trial feasibility and local resource utilization. Work with the Regions to ensure 100% allocation of all trials for assigned compound or compounds within the respective GPT/GMPT program portfolio
• Participate in the ICT and CTT meeting and give input on CDP and trial protocol feasibility based on CPO/ Region assessment.
• Agree with GPT/ICT/CTT/GMO on realistic project and trial timelines. Escalate to higher level in the organization if no agreement can be achieved.
• Provide common understanding to Clinical trial teams (CTTs) of the competitive environment in clinical trial conduct while leading the development and implementation of contingency plans
• Accountable for project/trial allocation plans within given indications and implementation following the global allocation strategy to ensure optimum patient accessibility, resource utilization / allocation and country/ region development, agree with the Global Trial Allocation Board.
• Ensure that local needs, e.g minimum requested number of patients for registration are considered in the allocation plan
• Determine external clinical trial costs and internal GMO monitoring resources for assigned projects. Negotiate trial costs with the CPOs. Monitor GMO resource requirements.
• Provide feedback to the program clinical team on the impact of changes to project status, timelines and overall monitoring resources.
• Provide feedback to the program clinical team on the impact of changes to project status, timelines and overall monitoring resources.
• Track global progress of clinical projects responsible for updating the planning and tracking systems, (i.e. TCFs and Clin Admin)
Minimum requirementsEducation:
• Life Science/Nursing degree or equivalent.
• Advanced degree is desirable.

Fluent English (oral and written)

• At least 7+ years experience in clinical development/project management, preferably as CTH or Sr. CTH.
• Minimum 2-4 years experience as Program/Regional Allocation Manager or similar function with > 6 years experience in clinical development/project management.
• Good leadership, negotiation and project management skills
• Demonstrated ability of establish effective working partnerships with regions, country organizations and clinical teams.
• Experience of managing resources
• Medical / Scientific knowledge of oncology therapy area and associated trial designs
• Demonstrated presentation and diplomacy skills
• Willingness to act accountably in project / trial management
• Familiar with planning, tracking and resource management tools.
• Robust knowledge of the regulatory and local requirements within regions and countries
• Expert skills to facilitate/optimize contribution of team members