CRO - Project Director

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Full Time Management US

Job Title:
Project Director

Department:
Project Management

Project Director provides leadership and support to members of assigned project teams. Responsibilities include oversight of the projects including budgeting, timeline adherence, internal and external communications, project deliverables and management of all Project Managers completing these tasks for assigned projects. In conjunction with Chief Operating Officer and the VP of Quality Operations, acts as a point of escalation and liaison between sponsors, team members, and the cross-functional organization for assigned projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES
include the following.

Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed below.

Support Projects by:

• Reviewing project KPI reports and compiling reports for senior management.
• Working with the Project Manager to ensure appropriate change management for assigned projects.
• Providing direction and serving as a point of escalation for project issues and risks.
• Overseeing development, governance, and implementation of processes, methodologies, tools for assigned projects/programs.
• Working with Directors to ensure appropriate project resources for assigned projects.
• Participating in the hiring of project management staff as needed.
• Interfacing with internal departments to develop organization work structure for programs.

Facilitate approval for project management deliverables for assigned project such as:

• Project Transfer of Responsibilities/Obligations document
• Project-specific plans/manuals, scope, timelines, and budget projections

Manage project management processes for assigned projects such as:

• Issue management
• Change control
• Quality management
• Client relationships

The Project Director may also serve as a Project Manager and as such would assume primary accountability for overall project scope, deliverables, budget, and timelines for assigned clinical research projects, ensuring compliance with applicable regulations, guidelines, and corporate policies for study activities.

Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.

Attends off-site meetings and conferences, as needed.

Ensures that project milestones are met and documented.

Position may not have direct supervisory responsibilities but works closely with assigned team members to ensure accountability. Position requires extensive experience and judgment to accomplish study defined goals. Ability to train and provide higher level guidance in the development of project management tools.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Bachelor’s degree or equivalent education/degree in life science/healthcare is required accompanied by a minimum of 4 years of working within clinical project management either at an investigational site, pharmaceutical company, or CRO, plus a minimum of 8 years of experience within clinical research. Prior CRO experience and experience supervising projects is highly desirable. This role requires extensive knowledge of the FDA submission process.

Ability to facilitate a teamwork philosophy with a positive attitude. Extensive supervisory, teaching and facilitation skills with…