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BeOne Medicines · 1 day ago

Global Clinical Study Manager

United States

Full-time

Remote

Senior Level

$119K/yr - $159K/yr

5+ years exp

BeOne Medicines is a rapidly growing company focused on fighting cancer, seeking an experienced Global Clinical Study Manager to oversee clinical studies. The role involves leading cross-functional teams, ensuring study delivery within timelines and budgets, and maintaining compliance with regulations.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

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

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

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

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

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

Provides performance feedback on team members as required

Qualification

Global clinical study managementOncology experienceProject managementClinical Trial Management SystemsBudget managementAnalytical thinkingCross-functional leadershipTeamworkCommunication skillsContinuous learning

Required

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