Senior Project Manager

Description

• 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.

Reporting and Communication:

• 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.

Business Development

Participates in bid defense meetings where presented as potential project manager/director.

• Develops strong relationships with current clients to generate new and/or add-on business for the future.
• 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

Qualifications