Respiratory Study Manager: Lead Clinical Trials & Delivery

Syneos Health/ inVentiv Health Commercial LLC; North Carolina; On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits (Medical, Dental, Vis​

401(k) match

Employee Stock Purchase Plan

Commissions/bonus based on performance

Paid time off (PTO) and sick time

Job summary

Syneos Health is seeking a Study Manager - Respiratory in the United States. You will oversee interdisciplinary clinical research studies, ensure GCP compliance, and act as the primary liaison with customers to drive study launches, conduct, and closeouts.

The role requires strong organizational skills, CRO/therapeutic experience preferred, and travel up to ~25%. Join a team focused on accelerating therapy development and delivering value to clients.

Qualifications

• Bachelor's Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
• Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• Strong organizational skills
• Strong ability to manage time and work independently
• Direct therapeutic area expertise
• Ability to embrace new technologies
• Excellent communication, presentation, interpersonal skills, both written and spoken
• Ability to travel as necessary (approximately 25%).

Responsibilities

• Project Leadership and Delivery. Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP's, 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 SOP's and regulatory requirements. Accountable for all project deliverables for each project assigned.
• Responsible for quality and completeness of TMF for assigned projects.
• Accountable for maintenance of study information on a variety of databases and systems.
• Responsible for study management components of inspection readiness for all aspects of the study conduct. Oversight for development and implementation of project plans.
• Plan, coordinate and present at internal and external meetings. Prepare project management reports for clients and management.
• Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• Develops strong relationships with current clients to generate new and/or add-on business for the future.
• May participate in bid defense meetings where presented as potential project manager.
• May be required to line manage other project management team members and clinical monitoring staff.

Skills

Excellent communication

Strong organizational skills

Time management

Independent work

Education

Bachelor's Degree (or equivalent) in Life Sciences/Medicine/Pharmacy/Nursing

Job description

Syneos Health is seeking a Study Manager - Respiratory in the United States. You will oversee interdisciplinary clinical research studies, ensure GCP compliance, and act as the primary liaison with customers to drive study launches, conduct, and closeouts.

The role requires strong organizational skills, CRO/therapeutic experience preferred, and travel up to ~25%. Join a team focused on accelerating therapy development and delivering value to clients.