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Home-Based Senior Project Manager (Real World Late Phase)

California All, CA

Job Type: Clinical Job Number: JN -102019-25758 Region: California All

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.)

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