Note: The job is a remote job and is open to candidates in USA. Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. The Senior Project Manager will oversee interdisciplinary clinical research studies, ensuring compliance with regulatory requirements while managing project timelines, quality, and financial performance.

Responsibilities

• 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

• Project Leadership and Delivery experience managing interdisciplinary clinical research studies
• Compliance with GCP, relevant SOP's, and regulatory requirements
• Acting as a primary liaison between the Company and the Customer
• Leading project team to ensure quality, timelines and budget management
• Accountability for the financial performance of each project
• Coordinating activities and deliverables of all study conduct partners
• Proactively identifying and managing issues
• Ensuring studies are conducted in compliance with GCP, relevant SOP's and regulatory requirements
• Accountability for all project deliverables for each project assigned
• Responsible for quality and completeness of TMF for assigned projects
• Accountability for maintenance of study information on a variety of databases and systems
• Responsible for study management components of inspection readiness
• Oversight for development and implementation of project plans
• Planning, coordinating and presenting at internal and external meetings
• Preparing project management reports for clients and management
• Developing contingency planning and risk mitigation strategies
• Developing strong relationships with current clients to generate new and/or add-on business
• Participation in bid defense meetings as potential project manager
• May be required to line manage other project management team members and clinical monitoring staff

Benefits

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Building an inclusive culture – where you can authentically be yourself

Company Overview

Company H1B Sponsorship