Clinical Project Manager II

azenta; Plainfield (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Azenta Inc. is seeking a Clinical Project Manager II to join its PMO within Azenta Life Sciences. You will lead cross-functional teams, manage client relationships, and ensure regulatory compliance across GMP/GxP environments.

Responsibilities include creating project plans, monitoring schedules, coordinating with vendors and clients, and contributing to continuous improvement initiatives. A science background and PM certification are preferred, with travel up to 10% as needed.

Qualifications

• Bachelor's degree in science or related field or equivalent with PM experience; HS diploma with 5+ years PM experience accepted
• Experience in FDA and GXP regulated environments
• Preferred master's degree in science or related field
• Preferred PM certifications: CSPO, CSM, PMP

Responsibilities

• Serve as the primary client contact for assigned projects and establish working relationships with client project teams.
• Ensure that all customer expectations are documented and acted upon in compliance with regulatory requirements.
• Create required project plans and monitor progress against them.
• Monitor project schedule and scope to ensure both remain on track.
• Provide project management support to internal teams and customers to deliver Azenta Life Sciences solutions.

Skills

Project management

Regulatory environments (FDA/GXP)

Communication

Vendor coordination

Education

Bachelor's degree in science or related field

High School Diploma with 5 years PM experience

Tools

PMP

CSPO/CSM

MS Office

Job description

Azenta Inc.

At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.

All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity

Job Title

Clinical Project Manager II

Job Description

At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.

Azenta Life Sciences is a global leader in the life sciences space with headquarters with offices and operations worldwide. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally.

How You'll Add Value:

The Clinical Project Manager within the Program Management Organization (PMO) is expected to provide project management support to internal team members, as well as customers, to deliver Azenta Life Sciences solutions (Long Term Sample Management, Active Clinical Trial Sample Management, Regulated Products (GMP/GTP) Management) to clients, partners, and alliances. Under guidance from the Director, Clinical Program Management or Program Manager, the Clinical Project Manager is expected to gain an in-depth understanding of the key clients and become an expert in Azenta Life Sciences services.

What You'll Do:

• Serve as the primary client contact for assigned projects and establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business
• Ensure that all customer expectations are documented and acted upon in compliance with regulatory requirements
• Able to act efficiently in an environment with dynamic timelines and priorities
• Accountable for the monitoring and reporting of performance metrics
• Create required project plans
• Implement and monitor progress against project plans and revise as necessary
• Monitor project schedule and scope to ensure both remain on track
• Project support may include kit provision and logistics, sample management, lab services support, relocation services, training, management, or support of alliances/ partnerships
• Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Azenta Life Sciences and client requirements
• Participate in pre-sale discussions and client meetings as required
• Actively participate in Azenta Life Sciences development through continuous improvement initiatives, contributing to Azenta's culture of quality and productivity initiatives including the development of new processes and SOPs, and the maintenance of SOPs to maintain audit-ready alignment with the Azenta Business Systems
• Mentor Client Coordinator as needed
• Managing queries and resolutions

What You Will Bring:

• Bachelor's degree in science or related field with a minimum of 2 years of project management experience
• OR High School Diploma or its equivalent and a minimum experience of 5 years of project management experience
• Experience working in an FDA and GXP regulated environments.
• Preferred master's degree in science or related field
• Preferred CSPO, CSM, PMP
• Strong organizational skills and attention to detail
• Excellent verbal and written communication skills; presentation skills, ability to engage in effective problem-solving conversations
• Demonstrated ability to collaborate and gain commitment from others
• Demonstrated ability to prioritize work, customers, internal and external demands
• Demonstrated ability to complete long-range projects as assigned

Your Working Conditions:

General office setting

The Employee may occasionally travel, up to 10% of working time

The Employee may occasionally work in an area with potentially infectious materials

The Employee will be responsible for maintaining a clean work environment and enforcing and following Universal Precautions for bloodborne pathogens when working in an area considered to be potentially contaminated

Join us and help enable life‑changing discoveries by keeping critical life science systems running reliably-every day.

#IND123

Azenta is an Equal Opportunity Employer. This company considers candidates rega