Clinical Study Manager | Global Trial Project Lead

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

Benefits offered by this job

Medical, Dental, Vision benefits

401(k) matching

Job summary

Syneos Health, a leading biopharmaceutical solutions organization, seeks a Study Manager in Respiratory to oversee interdisciplinary clinical studies from initiation through closeout. You will ensure adherence to GCP and regulatory requirements, while coordinating study teams and managing timelines, budgets, and TMF quality.

The role requires a Bachelor’s degree in life sciences or related field, CRO exposure, strong organizational and communication skills, and the ability to travel about 25% to

Qualifications

• Bachelor’s Degree in life sciences, Medicine, Pharmacy, Nursing or equivalent.
• Clinical research organization (CRO) experience preferred.
• Strong knowledge of Good Clinical Practice/ICH guidelines and regulatory requirements.
• Strong organizational skills and time management.
• Direct therapeutic area expertise and adaptability to new technologies.
• Excellent communication and interpersonal skills; willingness to travel ~25%.

Responsibilities

• Project leadership and delivery of interdisciplinary clinical research studies with compliance to GCP and regulatory requirements.
• Serve as primary liaison between Company and Customer to ensure timely study launch, conduct, and closeout.
• Lead project team to ensure quality, timelines, and budget management.
• Accountable for financial performance of each project and TMF quality for assigned studies.
• Coordinate activities of study conduct partners and manage issues.

Skills

Project leadership

GCP/ICH knowledge

Time management

Independent work

Therapeutic area expertise

Education

Bachelor’s degree in life sciences/medicine/pharmacy/nursing

Tools

TMF systems

Job description

Syneos Health, a leading biopharmaceutical solutions organization, seeks a Study Manager in Respiratory to oversee interdisciplinary clinical studies from initiation through closeout. You will ensure adherence to GCP and regulatory requirements, while coordinating study teams and managing timelines, budgets, and TMF quality.

The role requires a Bachelor’s degree in life sciences or related field, CRO exposure, strong organizational and communication skills, and the ability to travel about 25% to