Global Study Manager – FSP

• Deliver clinical operations activities for assigned studies through study archiving
• Generate accelerated delivery plans focused on upper-quartile performance and deliver against target or stretch thresholds with quality
• Work with the Global Study Lead on end-to-end clinical study delivery
• Accountable for operational delivery of clinical studies on time, within quality standards and budget, and according to scientific requirements
• Support decision-making and lead study teams to achieve study deliverables
• Lead or deliver study initiation meetings, clinical study activity plans, study delivery plans, TMF quality strategy documents, DCT setup, vendor oversight plans, investigator/CRA meetings and training, recruitment tracking, budget tracking, eTMF filing, vendor setup and management, and safety management plans
• Identify, oversee, and mitigate study risks
• Ensure stakeholder communication regarding study status, expectations, risks, and issues
• Operate within the study budget
• Lead empowered matrix teams
• Provide operational input into protocols, informed consent forms, and other key study documents
• Lead investigator meetings and other study-related meetings
• Lead quality efforts to ensure protocol compliance and continual inspection readiness
• Oversee activities of countries participating in the study

• Bachelor’s degree in life sciences or related discipline
• At least 5+ years of relevant global study management experience
• In-depth experience in clinical research, including study management, monitoring, and data management
• Previous in-depth oncology experience
• End-to-end global clinical study management experience across NA, EMEA, APAC, LATAM, China, and Japan; Africa experience is an asset
• Proven experience from study feasibility through Clinical Study Report (CSR)
• At least Phase II and Phase III experience; Phase I, PI, and PIV experience is an asset
• Proven cross-functional leadership experience and ability to drive internal and external meetings
• Ability to contribute to clinical protocols, informed consent forms, study plans, clinical study risk management, and clinical systems
• Strong clinical budget management experience
• Strong vendor management experience, including CROs
• Experience with competent authority inspections, including FDA, EMA, MHRA, and PMDA; involvement in pivotal drug-registration studies is an asset
• Fluent English sufficient to negotiate and discuss complex clinical topics and present status to upper management
• Excellent stakeholder management and oral and written communication skills
• Outstanding interpersonal skills
• Leadership skills promoting motivation and empowerment
• Strong understanding of clinical study, drug development, sample management, associated processes, and quality requirements, including ICH/GCP guidelines and SOPs
• Good project management skills, including scope, budget, timeline, resource planning and management, and associated tools

• Fully remote work arrangement
• Standard Monday–Friday work schedule