Senior Study Manager, Immunology

Merck · North Wales (upper Gwynedd), PA +2 more

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Clinical OperationsFull-time$117k–$184kCompany career page

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Role summary

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.

What they're looking for

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)

What you'll be doing

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

Key requirements

Therapeutic area: Immunology

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