Global Clinical Study Senior Manager (Senior gCSM)

Cross-Functional Leadership

• 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
• Participates in Clinical Operations Process improvement initiative

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
• Provides oversight to study start up and site activation plans
• Ensures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ...) are created, updated and distributed timely and implemented appropriately
• Ensures study systems and tools are set up timely, correctly and are functioning properly. Ensures study level information is updated on an ongoing basis in all systems
• Implements RBQM end-to-end processes on time within the allocated study (e.g., 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

• Monitors study activities to ensure compliance with the study protocol, SOPs, all study plans, ICH/GCP and all other relevant regulations
• Regularly reviews and manages quality-related GCO metrics to be within acceptable limits
• Ensures inspection readiness at any point in time throughout the study life cycle
• Works with cross-functional study team to identify, interpret, and evaluate issues on the study and ensures corrective and preventative actions are implemented
• 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
• Collaborates with CST members and other colleagues to ensure cross-team, site learnings, and best practices are shared
• Leads improvements and partners with study team members to enhance the efficiency and the quality of the work performed on assigned studies
• Contributes to development, optimization and review of work instructions and SOPs as required

Budget and Resources

• Works with the sourcing team to select and manage study vendors, approving invoice payment throughout the study
• 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
• Identifies and manages study team resource needs and establishes contingency plans for key resources.
• 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

Supervisory Responsibilities: Provides performance feedback on team members as required Qualification Required: Education Required:

Bachelor’s Degree in a scientific or healthcare discipline required*, Higher Degree preferred