Senior Immunology Study Lead – Clinical Trials

MSD Malaysia; North Wales (Montgomery County); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck is seeking an experienced Clinical Trials Operations Lead to drive planning and execution of one or more clinical trials within the Tulisokibart program, including feasibility assessment, country/site selection, data management deliverables, trial level plans and timelines, and investigator meeting planning.

You will lead teams, manage timelines and risks, coordinate with internal and external stakeholders, ensure adherence to GCP and ICH, and strive to meet study goals while maintaining

Qualifications

• Must have experience driving operational activities on clinical protocols.
• Experience representing company in external partnerships and collaborations.
• Solid knowledge of GCP and ICH regulatory requirements.

Responsibilities

• Lead operational planning, feasibility, and execution of one or more clinical trials or significant aspects thereof.
• May serve as the clinical trial team lead and oversee key planning, timelines, site materials, and vendor interactions.
• Manage timelines, risks, issues, and cross-functional collaboration with country teams, vendors, and study stakeholders.

Skills

Adaptability

Analytical Problem Solving

Clinical Development

Clinical Operations

Clinical Sciences

Conflict Management

Critical Thinking

Ethical Standards

Good Clinical Practice (GCP)

Partner Relationship Management (PRM)

People Management

Presentation Delivery

Process Improvements

Stakeholder Alignment

Strategic Thinking

Job description

Merck is seeking an experienced Clinical Trials Operations Lead to drive planning and execution of one or more clinical trials within the Tulisokibart program, including feasibility assessment, country/site selection, data management deliverables, trial level plans and timelines, and investigator meeting planning.

You will lead teams, manage timelines and risks, coordinate with internal and external stakeholders, ensure adherence to GCP and ICH, and strive to meet study goals while maintaining