Description
Syneos Health is seeking a Study Manager - Respiratory to oversee interdisciplinary clinical research studies, ensuring compliance with GCP, relevant SOPs, and regulatory requirements.
The successful candidate will act 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.
Key responsibilities include:
- Managing projects as a project manager overseeing interdisciplinary clinical research studies
- Ensuring compliance with GCP, relevant SOPs, and regulatory requirements
- Leading project teams to ensure quality, timelines, and budget management
- Coordinating activities and deliverables of all study conduct partners
- Identifying and managing issues proactively
- Ensuring studies are conducted in compliance with GCP, relevant SOPs, and regulatory requirements
- Maintaining study information on various databases and systems
- Preparing project management reports for clients and management
- Developing contingency planning and risk mitigation strategies
- Building strong relationships with current clients to generate new business
Requirements:
- Bachelor's degree 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
- Ability to manage time and work independently
- Direct therapeutic area expertise
- Excellent communication, presentation, and interpersonal skills
- Ability to travel approximately 25%
Benefits may include:
- Company car or car allowance
- Health benefits (medical, dental, vision)
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time