Senior Global Trial Manager

Working with Us

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Position Summary

• Provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.

• Independently leads complex, large, global in-house or outsourced, Non-Registrational Data Generating or Registrational Data Generating trials/studies at any point in the life cycle of the trial/study (i. e. start up, maintenance, or close-out).

• Acts as the primary operational contact for the study and leads the cross functional global team for execution of the study.

• May provide operational leadership of one or more cross-functional Study Team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.

• Has high global organizational impact and influence, and significant impact on function and Study Team.

Duties/Responsibilities

Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following:

Project Management

• Directs and delegates to the assigned Global Trial Management Staff as applicable.

• Drives study execution utilizing available performance metrics and quality indicators and study milestones and drivers.

• Oversees clinical monitoring quality and adherence to established processes and plans.

• Develops, manages, and maintains study deliverables (i. e. timelines, study plans, etc. ) through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data driven decisions.

• Proactively identifies potential risks and develops/implements actions to avoid/mitigate and make the appropriate trade-offs of balancing risks with study deliverables and costs.

• Maintains/updates data as appropriate in project management tools including CTMS.

• Troubleshoots complex issues with little guidance and support.

• Informs operational program lead(s) and other leadership (as appropriate) on overall clinical trial plans, recruitment status, and raises potential issues/mitigation.

• Leads, develops, and implements cross-functional/global initiatives and best practices.

• Creates, maintains, and implements project management tools at the study level (e. g. actions, decisions, issues log and risk management plan).

Study Planning and Conduct

• Supports and oversees country and site feasibility/selection processes with use of robust data.

• Provides operational and strategic input into Study Team and study documents.

• Collaborates with CSO on global investigational product [IP] supply forecasting/management.

• Participates in the subject recruitment/retention strategy and related initiatives (e. g. recruitment material).

• Participates in clinical service provider (vendor) selection, specification development, and management/oversight.

• Oversees TMF set-up, ongoing quality review, operational oversight memo, and requests final reconciliation.

• Provides input to and reviews study training for Study Team, investigational sites, and vendors in collaboration with the Clinical Scientist.

• Oversees study specific CSR appendices.

• Provides input and communicates with the appropriate teams for response to country/regulatory and IRB/IEC.

• Proactively manages issues and information sharing with key internal/external stakeholders with use of standardized reports and other mechanisms.

• Highly proactive risk identification, contingency planning, innovative problem solving, and the ability to solve multiple problems with varying degrees of complexity for multiple functions and understands when escalation is needed.

• Oversees service providers without supervision.

• Leads Audit Response Team and CAPA and participates in inspections.

• Supports the development/management/review vendor scope of work (SOW), invoices, and accruals as per the contract, quality requirements, and budget.

Relationship Management

• Proactively develops/maintains collaborative relationships with internal partners/stakeholders across the multidisciplinary teams.

• Manages external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers as applicable.

• Influences key stakeholders inside/outside of the team and capitalizes on established relationships.

Leadership Competencies

• Creates realistic plans that clearly define goals, milestones, responsibilities, and results.

• Maintains focus on strategic objectives while accomplishing operational goals.

• Places a priority on getting results with an emphasis on high quality outcomes.

• Holds self and others accountable for accomplishing goals.

• Makes timely, data-driven decisions while balancing against daily priorities.

• Develops and maintains effective working relationships with people across cultures.

• Encourages collaboration across teams, functions, and geographies.

• Ensures that conflict is handled constructively so that performance is not impacted.

• Displays a willingness to challenge the status quo and take risks.

• Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute.

• Maintains optimism and composure in times of change, uncertainty, or stress.

• Executes to deliver on corporate objectives and drives goals.

• Leads global cross functional therapeutic programs.

• Creates global solutions for processes.

• Acts as mentor, driver, and motiv.