Lead Global RWE Study Manager (Hybrid)

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

Benefits offered by this job

Discretionary profit share bonuses

Hybrid and flexible working options

Generous vacation allowance

Private medical and dental insurance

401K with up to 5% employer match

Job summary

Costello Medical, Inc. is seeking an experienced clinical research professional to join the RWE team in the Study Management sub-team, basing in Boston or New York with a preference for Boston.

The Senior role will independently manage study activities across a portfolio, serving as the primary contact for study management tasks, and ensuring ethical and regulatory compliance. This role offers strategic leadership, collaboration with international teams, and opportunities to develop best

Qualifications

• Minimum 2 years in a study management or clinical trial/study coordination role in the US.
• Degree in a scientific discipline.
• Understanding of RWE methods and study designs.
• Excellent written English and documentation skills.

Responsibilities

• Lead setup and management of de novo RWE studies (Phase IV, interventional, observational).
• Oversee IRB/IEC submissions, site feasibility, contracting, and local approvals.
• Develop and review study documents (protocols, regulatory submissions).
• Manage Site Initiation Visits, site meetings, and closure visits; assess feasibility.
• Monitor enrolment, milestones, and risks; manage CAPAs and safety plans.
• Oversee study budgets, invoicing, and documentation (Study/TMF).
• Collaborate with statisticians/epidemiologists for data analysis and reporting.
• Contribute to SOPs, internal training, and process improvements.
• Support business development, proposals, and US RWE growth.

Skills

Study management

RWE knowledge

Regulatory understanding

Stakeholder communication

Independent work

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, basing in Boston or New York with a preference for Boston.

The Senior role will independently manage study activities across a portfolio, serving as the primary contact for study management tasks, and ensuring ethical and regulatory compliance. This role offers strategic leadership, collaboration with international teams, and opportunities to develop best