Senior Start-up & Site Activation Leader - Clinical Trials

EMD Serono, Inc.; Billerica (MA); On-site; USD 129,000 - 193,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Perquisites

Job summary

EMD Serono, Inc. in the United States is seeking an experienced clinical research leader to serve as Associate Director, Start-up Lead, SiteID & Activation to drive start-up strategies across our global trial portfolio.

You will oversee country/site feasibility, regulatory submissions, and activations from protocol through implementation, collaborating with internal teams and external providers to accelerate timelines and ensure ICH-GCP compliance.

Qualifications

• Medical or Life Sciences degree or equivalent qualification.
• 10+ years in clinical research in a CRO or Pharmaceutical/Biotechnology industry.
• 5 years of project management and study start-up experience.
• Thorough knowledge of ICH-GCP and applicable laws and regulations for key countries.
• PM certification (CPM, PMP) preferred.

Responsibilities

• Oversee country and site feasibility assessments.
• Drive regulatory submissions and site activations from protocol through implementation.
• Collaborate with internal teams and external service providers to accelerate study timelines and optimize recruitment outcomes.
• Champion process improvements.
• Manage performance metrics.
• Drive operational excellence to bring medicines to patients faster.
• Ensure compliance with ICH-GCP standards and applicable regulations.

Skills

Project management

Clinical trial operations

Regulatory compliance

Data-driven decision making

Communication skills

Agile methodologies

Education

Medical or Life Sciences degree

PM certification (CPM, PMP)

Job description

EMD Serono, Inc. in the United States is seeking an experienced clinical research leader to serve as Associate Director, Start-up Lead, SiteID & Activation to drive start-up strategies across our global trial portfolio.

You will oversee country/site feasibility, regulatory submissions, and activations from protocol through implementation, collaborating with internal teams and external providers to accelerate timelines and ensure ICH-GCP compliance.