Clinical Project Manager II/ III

Job Purpose/ Summary: The Clinical Project Manager II/III is responsible for execution and oversight of assigned clinical trials (Phase I through Phase IV) to ensure client's goals of time, cost, and quality performance are met.

The CPM is expected to be independent but may require consultation and guidance from the trial-assigned Director to ensure successful clinical trial execution and to support other functional team members' management of daily trial operations.

Often functions as a global lead to provide client interface and oversight of trial regions' operational activities.

The CPM is seen as skilled in the application of the essential functions of the CPM role listed below.

What You'll Do:


* Plan, implement, evaluate, and complete full execution of assigned clinical trials; often functions as a global trial lead.


* Set goals, and timelines, provide oversight and positive leadership to foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned clinical trials.


* Provide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures.


* Provide management of a full scope clinical trial projects including global trials from start-up through analysis phase; provide oversight of functionally assigned teams members on clinical trials projects; able to effectively manage multiple projects simultaneously.


* Provide coordination of a clinical trial project including organization, implementation, and management of scoped activities


* Implement project activities according to scope of contracted work.


* Evaluate and manage project budget against project milestones and scope and collaborate with the trial assigned Director as needed to take corrective measures where necessary to keep project in line with budget.


* Regularly assess project profit margins with trial-assigned Director at the project and project service levels and work with the trial-assigned Director and project team to understand deficiencies; support and mitigation strategies to positively impact project profit margins.


* Assess scope of work against client contractual agreement and inform trial assigned Director of any concerns; facilitate change of scope orders when appropriate.


* Prepare or provide oversight and support to the development of trial plans, timelines, schedules, resources, and budgets; work with team and trial assigned Director to provide effective solutions to challenges that arise during the clinical trial project.


* Prepare or provide oversight and guidance in the development of trial required deliverables.


* Serve as client contact at project operational level.


* Provide oversight to contracted vendors; review contracted spec...