Senior RWE Study Manager – Global Trials (Hybrid)

Costello-Medical-1; New York (NY); Hybrid; USD 95,000 - 105,000; Full time

Benefits offered by this job

Profit sharing

Hybrid work

Vacation allowance

Private medical/dental

401K plan

Life insurance

Education funding

Job summary

Costello Medical, a global healthcare agency, is seeking an experienced clinical research professional to join the RWE team in the Study Management sub-team. Based in our Boston or New York offices, with a preference for Boston, you’ll lead setup and delivery of de novo RWE studies while collaborating across the international team.

You will independently manage study activities, provide strategic leadership, and ensure high-quality delivery aligned with ethical and regulatory standards.

Qualifications

• Minimum 2 years’ experience in a study management or clinical trial/study coordination role.
• Experience working in clinical research within the US.
• Understanding of RWE or clinical research methods and study designs.
• Ability to work independently and manage multiple study activities.
• Strong written communication and attention to detail.

Responsibilities

• Lead setup and management of RWE studies including Phase IV, interventional, non-interventional and observational studies.
• Oversee IRB/IEC submissions, site feasibility, contracting and local approvals.
• Develop and review study documents such as protocols and regulatory submissions.
• Conduct Site Initiation Visits and site meetings; identify feasible study sites.
• Monitor progress, enrolment milestones, and manage risks with CAPAs when needed.
• Oversee study budgets, invoicing, and Master/Trial Master File documentation.

Skills

Clinical research experience

RWE methods

US regulatory knowledge

Study management

IRB submissions

Education

Science degree

Tools

IRB submissions tools

Job description

Costello Medical, a global healthcare agency, is seeking an experienced clinical research professional to join the RWE team in the Study Management sub-team. Based in our Boston or New York offices, with a preference for Boston, you’ll lead setup and delivery of de novo RWE studies while collaborating across the international team.

You will independently manage study activities, provide strategic leadership, and ensure high-quality delivery aligned with ethical and regulatory standards.