Senior Global Clinical Study Manager

General Description

Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality for studies within partnership programs under the Clinical Superhighway. Leads all aspects of assigned clinical studies, leads the global cross-functional study team (including oversight of external partners), and acts as point of escalation for resolution of issues.

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 vendor 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.
• Represents the study team at internal meetings and leads the cross-functional Clinical Study Team (CST) meetings.
• Participates in Clinical Operations Process improvement initiatives.

Planning and Execution

• Leads planning and management of assigned clinical studies from feasibility through closeout activities.
• Generates, manages, maintains, and communicates high quality study timelines and tracks progress.
• 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 are created, updated, distributed timely and implemented appropriately.
• Ensures study systems and tools are set up timely, correctly and functioning properly.
• Implements RBQM end-to-end processes on time within the allocated study.
• Ensures relevant study specific training is developed and implemented and training records are documented and filed.
• Ensures Trial Master File is created, maintained and QC'd on a regular basis.
• Collaborates closely with Global Clinical Supplies to forecast study drug and timely delivery of supplies to sites.
• Supports overall data cleaning timelines in close collaboration with Data Management.
• Ensures planning and execution of the Clinical Study Report in collaboration with Medical Writing.

Quality and Risk Management

• Monitors study activities to ensure compliance with the study protocol, SOPs, study plans, ICH/GCP and other relevant regulations.
• Regularly reviews and manages quality-related GCO metrics to be within acceptable limits.
• Ensures inspection readiness at any point throughout the study life cycle.
• Works with cross-functional study team to identify, interpret, and evaluate issues and ensures corrective and preventative actions are implemented.
• Ensures senior management and key stakeholders are informed of risks and challenges and risk mitigation plans are implemented.
• Prepares team for quality assurance audits and inspections.
• Leads improvements and partners with study team members to enhance efficiency and quality.
• Leads development, optimization and review of work instructions and SOPs.

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, and 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.

Qualifications

• Proven Project Management experience in Global Clinical Studies (Oncology experience preferred).
• Advanced knowledge of clinical operations methodologies and in-depth understanding of all aspects of clinical study processes.
• Able to independently lead global clinical studies.
• 8 or more years of progressive experience in clinical research within biotech, pharma or CRO industry.
• Bachelor's degree in a scientific or healthcare discipline required; higher degree preferred.
• Travel up to 20%, domestically and internationally.
• Computer skills: MS Office; Project Planning Applications; Clinical Trial Management Systems (CTMS).