Note: The job is a remote job and is open to candidates in USA. Syneos Health is hiring an Early Phase Clinical Project Manager to lead interdisciplinary clinical research studies from launch through closeout. The role oversees study delivery, compliance, quality, timelines, budgets, project teams, client relationships, and inspection readiness.
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
- Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience
- 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
- Clinical research organization (CRO) and relevant therapeutic experience preferred
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Remote (Pre-Approved)
Company Overview
Company H1B Sponsorship