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The Strategic Planning & Feasibility (SPF) Manager 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. 

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.    

Major Accountabilities

Act as right-hand to support Strategic Planning & Feasibility Directors and Associate Directors on Program Feasibility and Trial Feasibility Teams (PFTs/TFTs) across assigned Development Unit(s) including but not limited to:

• Preparation and coordination of briefing information, training resources and other materials

• Project planning support and follow-up / management of key deliverables

• Assist assembly of actions, output summary and minutes for follow-up tracking

• Lead aspects of the feasibility activity as needed – e.g. feasibility survey consolidation and analysis, review of data insights with feasibility teams, etc.

• 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

• Conduct scenario planning and provide outputs of review from Footprint Optimizer (FPO) to assist with timeline review, validation of key data and support for Final Allocation Curve as part of handover

• Assist in portfolio management activities including tracking tollgates and preparation for risk review sessions; Involved in drafting risk slides and SPF overviews of current feasibility work as needed for senior management

• Ensure required end-of-feasibility information entry and compliance records into internal Novartis systems (e.g., IMPACT planning; archiving for Trial Master File and regulatory documents in CREDI / Subway, etc.)

• Manage early timeline and pricing assessments, including liaising with Health Insights and/or performing competitive intelligence general searches to build assumptions (includes archiving of outputs in team repositories)

• Logistics management of team meetings with agenda preparation, minutes and follow-up on action items

• Bachelors degree preferred.

• Fluent English – written and verbal.

• At least 3-4 years of experience in feasibilities process

• Prior experience in clinical trial support is preferred

• Excellent communication skills required

• Strong project planning and organizational capabilities needed

• Proven ability to work either independently or in team setting to meet goals within budget, timeline and compliance expectation

• Knowledge of Good Clinical Practice and understanding of overall drug development process

• Strong skills in MS Office Suite including: MS Teams, Excel, Word and can build and format PowerPoint slides at expert level.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com