Senior Global RWE Study Manager – Hybrid

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

Benefits offered by this job

Discretionary profit share

Hybrid work

Generous vacation

Private medical & dental insurance

401K with 5% match

Life insurance

Education funding & study leave

Sabbaticals

Social activities

Job summary

Costello Medical seeks an experienced clinical research professional to join our RWE team in Boston or New York. You will lead the setup and delivery of global de novo RWE studies, independently managing study and site activities and acting as the primary contact for study management tasks.

As a senior member, you will provide strategic leadership, ensure ethical and regulatory compliance, and contribute to the development of best practices while supporting business development and pipeline

Qualifications

• Essential requirements include a minimum of 2 years' experience in study management or clinical trial coordination.
• Experience in US clinical research and an understanding of RWE methods and study designs.
• Excellent written English, high attention to detail, and strong documentation skills (SOPs, protocols, study documents).
• Ability to work independently, manage multiple studies, and communicate with key stakeholders.

Responsibilities

• Lead setup and management of RWE studies (Phase IV, interventional/non-interventional, observational, market research).
• Oversee IRB/IEC submissions, site feasibility, contracting, and local approvals.
• Develop and review study documents (protocols, regulatory submissions).
• Conduct Site Initiation Visits, site meetings, and site closures; identify feasible study sites.
• Support data analysis and reporting with statisticians/epidemiologists; contribute to SOPs and training.
• Act as strategic advisor on study management, ethics, and regulatory compliance.

Skills

Clinical research experience

US experience

Communication skills

Written English

Attention to detail

Independence

Study management

Regulatory understanding

Education

Scientific degree

Job description

Costello Medical seeks an experienced clinical research professional to join our RWE team in Boston or New York. You will lead the setup and delivery of global de novo RWE studies, independently managing study and site activities and acting as the primary contact for study management tasks.

As a senior member, you will provide strategic leadership, ensure ethical and regulatory compliance, and contribute to the development of best practices while supporting business development and pipeline