Senior Manager, Clinical Trials

Job Description

Job Summary:

• The Senior Manager, Clinical Trials provides strategic and operational leadership to Clinical Trial Managers and associated study staff in support of global clinical programs.
• This role is accountable for the planning, execution, and oversight of RDN clinical trials, ensuring alignment with program strategy, timelines, budgets, quality standards, and regulatory requirements.
• The Senior Manager drives clinical excellence across studies, oversees vendor performance, and ensures audit readiness throughout the lifecycle of each trial.

Duties and Responsibilities:

• Lead, mentor, and develop Clinical Trial Managers and other assigned study personnel, fostering a high performance, collaborative team environment.
• Oversee end to end operational execution of global clinical trials, ensuring adherence to protocol, GCP, SOPs, and applicable regulatory requirements.
• Translate program strategy into operational plans, timelines, and resource needs; ensure cross functional alignment and timely delivery of study milestones.
• Oversee development and maintenance of study documentation, including operational plans, study materials, systems, and regulatory submissions.
• Manage CROs and external vendors, including selection, contracting, performance oversight, issue escalation, and budget tracking.
• Lead proactive risk identification, mitigation planning, and contingency management across assigned studies.
• Provide clear, data driven study updates, risk assessments, and recommendations to clinical leadership and governance bodies.
• Manage clinical trial budgets, including forecasting, accruals, variance analysis, and financial oversight of vendor contracts.
• Build and maintain strong relationships with investigators, clinical sites, and key opinion leaders to support enrollment, engagement, and study success.
• Ensure inspection readiness and compliance with internal quality standards, audit findings, and regulatory expectations.
• Champion continuous improvement in clinical operations processes, tools, and best practices.

Required qualifications:

• Bachelor’s degree in a scientific or healthcare discipline; advanced degree preferred.
• 10 years of experience in clinical research, including global clinical trials and vendor management.
• 5 years of demonstrated leadership experience managing and developing clinical trial staff, preferred.
• Strong understanding of GCP, ICH guidelines, and global regulatory requirements.
• Proven ability to manage complex timelines, budgets, and cross‐functional deliverables.
• Excellent communication, negotiation, and stakeholder‐management skills.
• Ability to navigate ambiguity, drive decision‐making, and influence across levels of the organization.
• Proven exposure and experience to internal audits and regulatory body audits.
• Ability to work in fast-paced environment requiring support of multiple studies and direct reports simultaneously.