Senior Study Manager, Immunology

Senior Study Manager position leading operational planning and execution of clinical trials within the immunology program. The role oversees feasibility assessments, protocol execution, cross-functional team coordination, and stakeholder engagement across global clinical development initiatives.

Responsibilities

• Lead operational planning, feasibility assessment, and execution of assigned clinical trials
• Serve as clinical trial team lead managing key planning, development, and execution activities
• Drive timeline management, risk identification/mitigation, and issue resolution across study teams
• Facilitate collaboration with internal/external stakeholders including study teams, vendors, and committees
• Manage study-specific partners and vendors while preparing status reports and coordinating investigator meetings

Requirements

• Bachelor's degree with 5+ years pharmaceutical/clinical drug development experience, or Master's degree with 3+ years relevant experience
• Solid knowledge of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) regulatory requirements
• Demonstrated project management and operational planning skills with ability to manage competing priorities
• Strong analytical, problem-solving, and critical thinking capabilities
• Excellent communication, writing, and presentation skills
• Experience conducting global clinical trials from initiation through database lock (preferred)
• Clinical trial experience in gastroenterology, dermatology, rheumatology, or immunology disorders (highly preferred)

Compensation: $117,000-$184,200 base