Senior Global Clinical Trial Manager

General Description Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality Leads all aspects of assigned clinical study(ies) Leads global cross-functional study team (including oversight of external partners) and acts as point of escalation for resolution of issues within assigned study(ies) Experience in managing global oncology studies; preferably pivotal studies and inspection management with HA Leads the global cross-functional study team effectively, ensures effective decision making, and acts as point of escalation for resolution of study related issues Leads external vendors management involved in study delivery Builds trust and relationship with regional subject matter experts and supports the delivery of their local study objectives Collaborates with key stakeholders across the organization and provides regular updates on study progress to senior management as required Represents the study team at internal meetings and leads the cross-functional Clinical Study Team (CST) meetings Participates and presents at various topics of Clinical Study Management Planning and Execution Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities Generates, manages, maintains, and communicates high quality study timelines and tracks progress towards these Ensures that the clinical studies are operationally feasible along with Global Clinical Program Lead, oversees trial feasibility, trial allocation and site selection process across all regions Ensures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBs Ensures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ...) periodic reviews, centralized monitoring analyses, action items) Ensures relevant study specific training is developed and implemented and ensures training records are well documented and filed Ensures Trial Master File for study is created, maintained and QC’d on a regular basis as per the study TMF QC plan Collaborates closely with Global Clinical Supplies to forecast study drug and timely delivery of supplies to sites Supports and as needed drives overall data cleaning timelines in close collaboration with Data Management and other stakeholders (including but not limited to regional clinical operations teams and medicator monitor) Ensures planning and execution of the Clinical Study Report in collaboration with Medical Writing and relevant CST members Quality and Risk Management Regularly reviews and manages quality-related GCO metrics to be within acceptable limits Ensures senior management and other key stakeholders are informed of risks and challenges and ensures risk mitigation plans are put in place and implemented Prepares team for quality assurance audits and inspections Leads improvements and partners with study team members to enhance the efficiency and the quality of the work performed on assigned studies Budget and Resources Manages study budgets, including baseline budget evaluation, change control, study closure budget, presents study budget for senior management engagement Adheres to clinical study budgeting processes and provides input to finance on budget accruals and forecasts Monitors Clinical Study Team resource utilization over the study life cycle Ensures clinical studies at a project level are executed within endorsed time, quality, and cost parameters Bachelor’s Degree in a scientific or healthcare discipline required*, Higher Degree preferred ~ Provides performance feedback on team members as required MS Office, Project Planning Applications, Clinical Trial Management Systems Proven Project Management experience in Global Clinical Studies (Oncology experience preferred) ~ Advanced knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processes ~ Able to independently lead global clinical studies (pivotal study management experience required) ~5+ years of progressive experience in clinical research within a biotech or pharma company ~ A minimum of 3 years working as a lead Senior Project Manager/Clinical Study Manager on Global Clinical Studies focused in Oncology ~ Prior experience in managing early (Phase 1-2) and/or late-stage pivotal studies (phase 3) in Breast Oncology Studies (preferred) Global Competencies Analytical Thinking/Data Analysis