Senior Clinical Trial Operations Lead

Merck; San Diego (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Merck in San Diego seeks an experienced Clinical Trials Program Lead to drive operational planning and execution of one or more trials in our portfolio. You will lead cross-functional teams, apply project management, regulatory knowledge (GCP/ICH), and strengthen collaboration with country sites and vendors.

The role focuses on timeline management, risk mitigation, and study-wide communications, including data management deliverables, site materials, and status reports.

Qualifications

• Bachelor's Degree with 5+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience.
• Master's Degree with 3+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience.
• PhD/PharmD Degree in life sciences is acceptable.
• Degree in life sciences, preferred.

Responsibilities

• Operational planning, feasibility, and execution of a clinical trial.
• May serve as the clinical trial team lead.
• Lead study planning, development, and execution elements (data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, status update reports, study close out activities).
• Leads team for timeline management, risk identification and mitigation, issue resolution.
• Facilitate and collaborate with internal/external stakeholders (study team, country teams, vendors, committees) in support of clinical study objectives.
• Accountable for managing any study specific partners and/or vendors.

Skills

Operational planning

Clinical trial management

GCP/ICH knowledge

Multi-tasking & prioritization

Project planning

Analytical skills

Stakeholder management

Communication skills

MS Office proficiency

Education

Bachelor's Degree + 5+ years

Master's Degree + 3+ years

PhD/PharmD Degree

Life sciences degree preferred

Job description

Merck in San Diego seeks an experienced Clinical Trials Program Lead to drive operational planning and execution of one or more trials in our portfolio. You will lead cross-functional teams, apply project management, regulatory knowledge (GCP/ICH), and strengthen collaboration with country sites and vendors.

The role focuses on timeline management, risk mitigation, and study-wide communications, including data management deliverables, site materials, and status reports.