Senior RWE Study Manager – Global, Hybrid

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

Benefits offered by this job

Profit sharing

Hybrid work options

23 days vacation

Job summary

Costello Medical is seeking an experienced clinical research professional to join our RWE team. Based in our Boston or New York offices, you will independently manage study activities, lead site contacts, ensure ethical and regulatory compliance, and help shape global de novo RWE delivery.

You will oversee study budgets, collaborate with statisticians, and contribute to SOPs and best practices while supporting business development and expansion of US RWE capabilities.

Qualifications

• Minimum 2 years’ experience in a study management or clinical trial/study coordination role.
• Experience in US clinical research and regulatory environments.
• Understanding of RWE concepts, study designs, and regulatory guidelines.

Responsibilities

• Lead setup and management of RWE studies, including Phase IV and observational studies.
• Oversee IRB/IEC submissions, site feasibility, contracting, and local approvals.
• Develop and review protocols and regulatory submissions.
• Conduct Site Initiation Visits and site meetings across multiple jurisdictions.
• Main point of contact for study sites; manage communications and deliverables.
• Monitor progress, enrolment, milestones; manage risks and CAPAs.
• Oversee budgets, invoicing, and regulatory documentation.
• Collaborate with statisticians for data analysis and reporting.
• Contribute to SOPs, training, and process improvements.
• Support business development and expansion of US RWE capabilities.

Skills

RWE knowledge

Study management

Leadership

Written communication

Attention to detail

Stakeholder management

Education

Science degree

Job description

Costello Medical is seeking an experienced clinical research professional to join our RWE team. Based in our Boston or New York offices, you will independently manage study activities, lead site contacts, ensure ethical and regulatory compliance, and help shape global de novo RWE delivery.

You will oversee study budgets, collaborate with statisticians, and contribute to SOPs and best practices while supporting business development and expansion of US RWE capabilities.