Project Coordinator, Compliance Management

Senior Project Manager
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.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

supportive and engaged line management; technical and therapeutic area training; We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Project Leadership and Delivery:
Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements.
Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement.
Leads clinical team to ensure quality, timelines and budget management.
Accountable for the financial performance of assigned projects
Accountable for all project deliverables for assigned projects and/or project regions.
Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues.
•
Accountable for maintenance of project information on a variety of databases and systems.
Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files.
Provides oversight for development and implementation of project plans in accordance with Controlled Documents.
Independently prepares, coordinates, and presents project material at internal and external meetings.
Directs the activities of assigned Project Support staff; line manages and mentors other project management team members and clinical staff; facilitates team building and communication.
Prepares project management reports for clients and management.
Implements resource strategies to achieve project goals.
Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals.
•
Participates in bid defense meetings where presented as potential project manager/director.
Keeps a current awareness of business unit’s and assigned projects’ therapeutic environment and drug development trends
•
Management:
May train and support new Project Managers. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.
May be required to line manage other project management team members and clinical monitoring staff

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

Further, nothing contained herein should be construed to create an employment contract. 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.
The position provides customer focused leadership in managing and delivering the operational and financial aspects of one or more clinical projects from proposal development to final deliverables and ranging in size and complexity from single service studies to full scope, multiple protocol projects and/or global projects across various phases and functional areas with limited interaction from supervisor. May oversee less experienced Project Managers (PMs) and have line management responsibilities.