Senior Real-World Evidence Study Lead (Hybrid)

Costello Medical, Inc.; Boston (MA); Hybrid; USD 95,000 - 105,000; Full time

Benefits offered by this job

Discretionary profit share

Hybrid work

Generous vacation

Private medical insurance

Dental insurance

401K with employer contribution

Life insurance

Study leave

Education funding

Sabbaticals

Company events

Job summary

Costello Medical, Inc. is seeking an experienced clinical research professional to join the RWE team in the Study Management sub-team. The role can be based in Boston or New York, with a preference for Boston, offering hybrid work and extensive cross-border collaboration.

You will independently manage study and site activities across a portfolio of projects, act as the primary contact for study management tasks, and ensure ethical and regulatory compliance while delivering high-quality results.

Qualifications

• Minimum 2 years’ experience in study management or clinical trial coordination.
• Experience working in clinical research within the US.
• Strong written communication and high attention to detail.

Responsibilities

• Lead setup and management of de novo RWE studies across global sites.
• Oversee IRB/IEC submissions, site feasibility, contracting and local approvals.
• Develop study documents and regulatory submissions.
• Conduct Site Initiation Visits and site meetings; manage risks and CAPAs.
• Monitor budgets, invoicing, and quality documentation; support data analysis.

Skills

Clinical research

US experience

Written communication

Attention to detail

Education

Scientific degree

Job description

Costello Medical, Inc. is seeking an experienced clinical research professional to join the RWE team in the Study Management sub-team. The role can be based in Boston or New York, with a preference for Boston, offering hybrid work and extensive cross-border collaboration.

You will independently manage study and site activities across a portfolio of projects, act as the primary contact for study management tasks, and ensure ethical and regulatory compliance while delivering high-quality results.