Global Clinical Study Manager

Job Title

Accountable for global study delivery with appropriate, inspection readiness quality, within agreed timelines and budget. 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). Ensures alignment of study goals with clinical operations and corporate goals and objectives. Experience in managing global pediatric studies; preferably in oncology.

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 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.

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, 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. 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, ICH / GCP and all other relevant regulations. 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, budget endorsement by senior management. 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 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.

Computer Skills

MS Office, Project Planning Applications, Clinical Trial Management Systems

Other Qualifications

Proven project management experience in global pediatric studies. Oncology experience preferred. Advanced knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processes. Able to independently lead large and / or complex global clinical studies. 5 or more years of progressive experience in clinical research within biotech, pharma or CRO industry.

Travel

Limited travel required

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.