Governance Senior Manager

The Governance Senior Manager provides leadership and expert guidance for governance and clinical excellence activities across the Governance and Clinical Excellence group. This role has primary accountability for the Study Review Committee (SRC) governance review processes under CT02, CT45 and CT19 SOPs, and is responsible for shaping the governance framework that supports high quality protocol, operational plan, and RQP reviews.

The Senior Governance Manager drives continuous improvement, oversees the design and implementation of SRC metrics, and ensures governance systems operate with efficiency, compliance, and transparency. This role provides strategic partnership to governance leadership, Business Process Owners (BPOs), clinical teams, and cross functional stakeholders. The position also leads complex governance initiatives, manages largescale process improvements, and influences enterprise wide standards.

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.

Responsibilities for include but are not limited to the following:

Scope of Responsibility and Team Influence:

• Provides leadership to the R&D SRC governance process, ensuring consistent endorsement of protocols, operational plans, and RQPs across programs and therapeutic areas.
• Oversees and shapes the SRC metrics collection and reporting, including development, refinement, and interpretation of metrics used to evaluate compliance, quality trends, and process optimization opportunities.
• Leads resource and technology planning across governance systems such as the Governance Navigator and PleaseReview, anticipating organizational needs and preparing for future capacity demands.
• Provides oversight to the Navigator System, ensuring prioritization, scheduling, and reviewer allocation optimize efficiency and quality across governance pathways.
• Applies advanced project management, change‑leadership, and continuous improvement methodologies to drive governance excellence.
• Establishes governance communication standards and ensures effective stakeholder engagement across clinical teams, boards, and functional partners.
• Oversees complex administrative and operational processes associated with SOP process, ensuring standardization and timely execution, supports the CT05 and CT40 BPOs with day-to-day process work
• Supports other governance staff, guiding execution of governance‑related analyses, metrics, and process enhancements.

Knowledge and Skills

• Recognized internal expert in continuous improvement, clinical governance models, and operational excellence.
• Knowledge of clinical development processes, project management methodologies, and governance frameworks.
• Serves as a technical and strategic resource, advising clinical and operational stakeholders on governance best practices, including CT05 and CT40 SOP knowledge to facilitate BPO support
• Applies understanding of internal and external clinical landscape to anticipate risk, identify opportunities, and drive enhancements to governance models.
• Champions innovative approaches and data analytics to elevate governance efficiency and maximize business value.

Decision Making and Autonomy

• Review launches and closures: troubleshooting of document issues with SME to ensure timely and quality review cycles. Guides teams to support documentation for launch, closure, and response distribution and working with Business Technology SMEs to support functionality
• Exercises significant autonomy in shaping governance process and metrics that may require developing new options to resolve complex problems such as governance portal updates and governance metrics development
• Makes decisions guided by clinical trial and study management policies in unusual or atypical situations, able to operate independently in ambiguous situations related to governance process, e.g. expedite joint DRC/SRC reviews
• Makes strategic decisions influencing multiple clinical programs, governance workflows, and delivery timelines with impact on the work of multiple clinical study, program teams and business units
• Exercises own judgment utilizing breadth of knowledge and prior work experience to implement metrics for continuous improvement. May become a resource for others
• Mostly reviews own work, solicits directional review from others such as the Governance Lead and Governance Head and may review work completed by other colleagues when acting in a mentor role

Leadership

• Leads governance wide strategic initiatives, including major enhancements to the Governance Navigator