Senior Real-World Evidence Study Manager

Costello-Medical-1; Boston (MA); 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 contrib.

Life insurance

Training funding and study leave

Job summary

Costello Medical is seeking an experienced clinical research professional to join the RWE team. Based in our Study Management sub-team, you will lead the setup and delivery of global de novo RWE studies, with a preference for Boston and extensive collaboration with our international team.

As a senior member, you will manage studies and site activities, provide strategic leadership, ensure ethical and regulatory standards, and contribute to SOPs and best practices while supporting business

Qualifications

• A minimum of 2 years’ experience in study management or clinical trial coordination.
• Experience working in clinical research within the US.
• A degree level qualification in a scientific discipline.
• Awareness of RWE or clinical research methods and study designs.
• Understanding regulations across geographies in clinical research.
• Excellent attention to detail and written English.
• Ability to prepare SOPs, study protocols and essential documents.
• Strong stakeholder communication abilities.
• Work independently with initiative in a fast-paced environment.

Responsibilities

• Lead setup and management of RWE studies across phases.
• Oversee IRB/IEC submissions, site feasibility, contracting and approvals.
• Develop and review protocols and regulatory submissions.
• Conduct Site Initiation Visits and site meetings.
• Be primary contact for study sites and ongoing support.
• Monitor progress, enrolment, milestones, and risk management.
• Oversee budgets, invoicing and trial master file documentation.
• Collaborate with statisticians and epidemiologists for analysis.
• Contribute to SOPs, training and process improvements.
• Support business development and expand US RWE capabilities.

Skills

Study management

Clinical research

Stakeholder communication

Regulatory awareness

Written English

Education

Degree in scientific discipline

Job description

Costello Medical is seeking an experienced clinical research professional to join the RWE team. Based in our Study Management sub-team, you will lead the setup and delivery of global de novo RWE studies, with a preference for Boston and extensive collaboration with our international team.

As a senior member, you will manage studies and site activities, provide strategic leadership, ensure ethical and regulatory standards, and contribute to SOPs and best practices while supporting business