Infectious Disease Clinical Study Manager

1001 Syneos Health, LLC; North Carolina; Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health benefits

401k matching

Stock Purchase Plan

Commissions/bonus eligibility

Flexible PTO

Job summary

Syneos Health is seeking a Study Manager for Infectious Disease to oversee interdisciplinary clinical research studies, ensuring GCP compliance, timelines, budgets, and TMF quality. You will act as the primary liaison with customers to ensure smooth study launches and closeouts within contractual agreements.

The role requires strong organizational skills, CRO/therapeutic experience, and the ability to travel ~25% to sites and meetings. A Life Sciences degree and ICH knowledge are essential.

Qualifications

• Bachelor's Degree in life sciences, medicine, pharmacy, nursing or equivalent.
• CRO experience and therapeutic area knowledge preferred.
• Strong knowledge of Good Clinical Practice/ICH guidelines and regulatory requirements.
• Excellent communication and ability to travel ~25%.

Responsibilities

• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOPs, and regulatory requirements.
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
• Lead project team to ensure quality, timelines and budget management.
• Accountable for the financial performance of each project.
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Ensure studies are conducted in compliance with GCP, relevant SOPs and regulatory requirements.

Skills

GCP knowledge

Strong organizational skills

Time management

Independent work capability

Communication skills

Travel readiness

Education

Bachelor’s Degree in life sciences or equivalent

Job description

Syneos Health is seeking a Study Manager for Infectious Disease to oversee interdisciplinary clinical research studies, ensuring GCP compliance, timelines, budgets, and TMF quality. You will act as the primary liaison with customers to ensure smooth study launches and closeouts within contractual agreements.

The role requires strong organizational skills, CRO/therapeutic experience, and the ability to travel ~25% to sites and meetings. A Life Sciences degree and ICH knowledge are essential.