Senior Manager, Clinical Trial Management – FSP

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead cross-functional trial teams and manage the comprehensive delivery of clinical trials.

• Develop and implement operational plans for trials.

• Supervise trial execution, including budgets, timelines, quality, milestones, and pathways for resolving protocol deviations.

• Identify, establish, and oversee relationships with CROs/vendors, manage statements of work, budgets, KPIs, and performance metrics.

• Ensure that trial deliverables and milestones align with corporate and study-level objectives.

• Identify potential risks and execute mitigations and contingency plans.

• Ensure adherence to global health authority regulations, guidelines, and internal protocols.

• Engage in Health Authority Inspections and internal quality assurance audits.

• Maintain readiness for inspections and collaborate with R&D Quality on quality oversight.

• Contribute to process improvement initiatives at both the trial and departmental levels.

• Mentor and assist in the onboarding of new team members, especially in Study Management.

• Collaborate with various departments including Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, and Medical Affairs.

• Analyze budget variances and inform Finance of projected over/under expenditures.

• Assist in preparing internal governance presentations and updates.

⛳️ Requirements

• A BS/BA degree is mandatory.

• At least 7+ years of clinical research experience, specifically with a CRO, Biotech, or Pharmaceutical Company, leading Phase 1–4 global clinical trials from start to finish.

• 3–5 years of direct experience in managing end-to-end global clinical trials.

• Proven experience overseeing global trials outsourced to a CRO vendor and managing all facets of clinical trial execution.

• Strong decision-making, analytical, and financial management abilities.

• Exceptional leadership qualities with the capacity to enhance team productivity and cohesiveness.

• Ability to function and execute tasks with minimal supervision.

• Experience in leading without direct authority in multifunctional, matrixed, and global settings.

• Background in mentoring and coaching others.

• Outstanding organizational skills with the ability to juggle competing priorities.

• Strong reasoning and problem-solving capabilities.

• Excellent project planning and management skills along with written, verbal communication, and presentation abilities.

• Proficient in MS Office Suite (Excel, Word, PowerPoint) and MS Project.

🏝️ Benefits

• Equal opportunity employer.

• Opportunity to travel approximately 10% with flexibility based on business needs.