Clinical Trial Manager — Deliver Timely, High‑Quality Data

Creative Solutions Services, LLC; Boston (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Clinical Study Manager/Lead for low to moderate complexity studies in a regulated environment. You will direct operational and quality activities, develop tools, and coordinate cross-functional teams to meet client timelines and quality expectations.

Responsibilities include overseeing TMF setup, tracking progress, and ensuring regulatory compliance with ICH/GCP and FDA guidelines, while maintaining profitability and efficient resource use.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 5+ years' experience in clinical project management or similar.
• Strong leadership, planning, budgeting, and communication skills.
• Familiarity with ICH/GCP, FDA guidelines, and regulatory expectations.

Responsibilities

• Manages all clinical operational and quality aspects of allocated studies (low to moderate complexity).
• Develops clinical tools and ensures timely Trial Master File organization.
• Leads team meetings and coordinates with other departments to meet deliverables.
• Monitors timelines, resources, and budgets to ensure contractual obligations.
• Coordinates start-up activities and regulatory submissions as appropriate.
• Archives documents and study materials in line with policies.

Skills

Leadership

Planning

Interpersonal skills

Change management

Clinical monitoring

Decision making

Communication (English)

Budgeting

Attention to detail

Regulatory knowledge

Computer skills

Education

Bachelor's degree

5+ years experience

Job description

Creative Solutions Services, LLC is seeking a Clinical Study Manager/Lead for low to moderate complexity studies in a regulated environment. You will direct operational and quality activities, develop tools, and coordinate cross-functional teams to meet client timelines and quality expectations.

Responsibilities include overseeing TMF setup, tracking progress, and ensuring regulatory compliance with ICH/GCP and FDA guidelines, while maintaining profitability and efficient resource use.