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Home-Based Senior Project Manager (Real World Late Phase)
California All, CA
Job 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 Real World Late Phase 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
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
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
Must Haves:
Bachelor s Degree
Recent CRO Clinical Project Management experience
At least 5 years of full scope PM experience with 3 years of Global PM experience
Bid Defense experience
Full Scope PM experience: experience independently managing trials (from start up to close out) and overseeing all aspects of clinical trials (managing budgets, managing cross-functional teams, risk mitigation, managing timelines/deliverables, main point of contact for clients, etc.)