CRO - Project Director

Lotus Clinical Research, LLC; Northern (KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Lotus Clinical Research, LLC is seeking a Project Director to provide leadership for assigned clinical programs. You will manage budgets, timelines, and deliverables while coordinating with sponsors, internal teams, and external partners.

The role may involve escalation support and governance for processes across projects. The position requires a Bachelor’s degree in life science/healthcare and extensive clinical research experience, including CRO exposure and FDA submission knowledge, with

Qualifications

• Bachelor’s degree in life science or healthcare.
• 4+ years of experience in clinical project management (investigational site, pharma, or CRO).
• 8+ years of experience in clinical research.
• Prior CRO experience and experience supervising projects is highly desirable.
• Knowledge of FDA submission processes is required.

Responsibilities

• Lead and support project teams; oversee budgeting, timelines, and deliverables.
• Act as escalation point between sponsors, team members and cross-functional orgs.
• Coordinate resources and governance for assigned programs and projects.
• Facilitate development and implementation of project management processes and tools.
• Participate in hiring and mentoring of project management staff as needed.

Skills

Team leadership

Project coordination

Multi-tasking

Communication

Can-do attitude

MS Office

Education

Bachelor’s degree in life science/healthcare

Tools

Microsoft Office

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

CRO - Project Director

Full Time Management US

Job Title: Project Director

Department: Project Management

PURPOSE

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.

SUPERVISORY RESPONSIBILITIES

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.

QUALIFICATIONS

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.

EDUCATION and/or EXPERIENCE

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.

SKILLS and/or ABILITIES

Ability to facilitate a teamwork philosophy with a positive attitude. Extensive supervisory, teaching and facilitation skills with the ability to assess training needs and objectives. Extensive experience overseeing and coordinating the work of others. Ability to work effectively and efficiently handling multiple tasks simultaneously. Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity. Ability to manage multiple deadlines. Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects. Strong computer skills, including Microsoft Office.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee regularly reaches with hands and arms. The employee periodically is required to lift and/or carry up to 10 pounds. Occasionally, employee stoops, bends, kneels, and crouches; and pushes/pulls filled wheeled carts. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Work in a home environment where the noise level is usually largely controlled by the employee, and a travel environment where the noise level is usually moderate to high. Employee is subject to many interruptions; pressure due to deadline requirements; and handling multiple tasks simultaneously while performing assigned duties.

SAFETY REQUIREMENTS

Employee is required to pay particular attention to safety in their home and travel environment.