Study Manager - Respiratory

Syneos Health, Inc.; Morrisville (NC); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits including Medical, Dental and Vision

Company match 401(k)

Employee Stock Purchase Plan

Flexible paid time off

Job summary

Syneos Health, Inc. located in Morrisville, NC, is seeking a Project Manager to oversee clinical research studies. The successful candidate will manage projects to ensure compliance and timely deliverables while coordinating with clients and teams.

A Bachelor’s degree in a relevant field is required, along with strong organizational and communication skills. Benefits include health coverage, 401(k) match, and flexible paid time off.

Qualifications

• Must have experience in a clinical research organization (CRO).
• Strong knowledge of Good Clinical Practice/ICH guidelines required.
• Ability to travel as necessary (approximately 25%).

Responsibilities

• Manage project overseeing interdisciplinary clinical research studies.
• Primary liaison between the Company and Customer.
• Ensure compliance with GCP and regulatory requirements.

Skills

Strong organizational skills

Excellent written and spoken communication

Ability to manage time

Direct therapeutic area expertise

Ability to embrace new technologies

Education

Bachelor’s Degree in life sciences, Medicine, Pharmacy, Nursing

Job description

Updated: Yesterday

Location: Morrisville, NC, United States

Job ID:25108965

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Job Responsibilities

• Project Leadership and Delivery – Manage a project as a project manager overseeing interdisciplinary clinical research studies and ensuring compliance with GCP, relevant SOP’s, and regulatory requirements.
• Primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the 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 and be accountable for all project deliverables.
• 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.
• Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• Develop strong relationships with current clients to generate new and/or add‑on business for the future.
• May participate in bid defense meetings when presented as a potential project manager.
• May be required to line‑manage other project management team members and clinical monitoring staff.

Qualifications

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

Benefits

• Company car or car allowance.
• Health benefits including Medical, Dental and Vision.
• Company match 401(k).
• Eligibility to participate in Employee Stock Purchase Plan and earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time, including compliance with applicable federal, state and municipal paid sick time requirements.

EEO Statement

Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate to assist employees or applicants to perform the essential functions of the job.