Project Manager

 The Project Manager oversees the conduct of Quality Assurance (QA) services provided by FDAQRC Consultants to Clients using strong clinical QA technical and supervisory management experience. Primary Duties and Responsibilities The position is full-time and home-based. Candidates must reside in the United States. Travel for internal business and to visit customers may occur.

Employees of FDAQRC have a flexible working schedule and may be required to work outside of traditional hours to meet deliverable timelines.

FDAQRC has two (2) customers; Clients and Consultants. Customer service is what makes us successful and therefore each employee is expected to understand and demonstrate far above average customer service skills. This results in high retention of our customers.

Clients:

● Ensure client needs are identified and exceeded through effective project oversight

● Respond to queries and follow-up on pending items through proactive communication

● Participate in the customer service program (sending and completing surveys)

● Review feedback and action any quality issues

Consultants:

● Proactively engage consultants

● Manage consultant relationships

● Facilitate communication through various methods (email, phone, etc.)

● Ensure information is rapidly disseminated

● Provide materials so the project is set-up for success

● Provide support through the time and expense review processes

● Review feedback and action any quality issues

The Project Manager performs a wide range of duties, including some or all the following:

● Identifying and interviewing new consultants

● Conducting project management duties such as:

• Conducting kick-off meetings and project status calls
• Completing meeting minutes and maintaining the Collaboration Plan
• Fulfilling both Client and Consultant needs
• Tracking deliverables/reports and updating project Stakeholders
• Evaluating the project against success criteria

● Conducting peer reviews of deliverables/reports

● Supporting the needs of the FDAQRC Quality Management System (QMS)

● Conducting services in technical areas of expertise

Experience

1. At least five (5) years of technical clinical QA auditing experience

2. A minimum of two (2) years of direct supervision of GxP QA personnel

3. Additional experience in project management is highly desirable 4. Quality (e.g., RQAP-GCP, CQA) certification is highly desirable

5. Multi-language skills are desirable

Additional Requirements

1. High speed internet and a dedicated work space is required

2. Flexible work hours may be required to meet company needs and deadlines

3. Ability and willingness to meet and/or exceed productivity and metrics

4. Must be authorized to work in the United States