Project Manager II

Summary of Objective:

Under general supervision of the Sr. Project Manager, Sr. Program Manager, or Manager, Project Management, the Project Manager II position will primarily manage multiple clinical projects of moderate complexity, and may be asked for participation in at least one larger, more complex project. Oversee the general day-to-day project planning to ensure on-time completion of project tasks, activities, and deliverables as scheduled. The Project Manager II position will serve as a liaison between PCI and clientele, ensuring excellent customer service and client satisfaction, and will be responsible for all aspects of their projects over the entire life cycle (initiate, plan, execute, control, and close), while ensuring consistency with company strategy, commitments and goals.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Comply with PCI Project Management procedures and policies

• Manage multiple clinical projects, primarily Tier II (moderate complexity) and Tier III (moderate to high complexity) projects for any North American site.

• Provide project leadership, coordination, and support for multidisciplinary project teams.

• Develop and maintain client-business relationships.

• Serve as primary point of contact for clients, driving project strategy, and managing communications with internal and external stakeholders.

• Ensure successful kick-off of projects and facilitate required technical transfer information gathering by both internal and external resources.

• Manage cross functional team by coordinating internal resources and client priorities

• Ensure that the project schedule encompasses the project scope and associated details are accurately developed and maintained.

• Ensure equipment and materials are identified and purchased in a timely manner, as applicable.

• Serve as the project lead for multiple projects; developing and maintaining a project schedule to track milestones; developing and executing plans for managing risk; escalating project-related issues to management in accordance with project guidelines and requirements; coordinating production issue resolution; interpreting data to help guide teams towards issue resolution and risk management; making recommendations regarding solutions to problems or issues; and presenting project status updates to senior leadership and key stakeholders.

• Assess client requests and ensure scope changes are communicated to BD for a change order, communicate scope change concerns to Management., and to other departments as necessary.

• Resolve client issues and escalate to PM Management as necessary.

• Ensure timely review and updates of documentation (MCP's, batch records, validation protocols, etc.) associated with each project.

• Ensure daily communication of operational status and issues to affected staff and management.

• Ensure samples are shipped to testing labs and results are provided to all relevant team members and stakeholders.

• Seek and implement continuous improvement strategies and develop/implement metrics to ensure adherence to established expectations.

• Expected to support project activities outside of core hours as necessary.

• May lead or participate in internal initiatives, as appropriate.

• Serve as a mentor for other Project Management team members, as applicable.

• Comply with all PCI policies and procedures.

• Perform other duties as assigned.

• Adept and proficient with Project Management software such as Microsoft Word, Excel, Access, Project, and Smartsheet.

• Competence and proficient in planning and organizing projects and programs.

• Demonstrated proficiency in critical thinking and problem-solving skills.

• Excellent written and verbal communication skills and strong competencies in customer relationship management.

Special 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Skilled at resolving conflicting situations by maintaining high ethics and values.

• Ability to work independently with minimal supervision through coaching and guidance to succeed.

• Proficiency at working in a fast-paced work environment.

• Honesty, integrity, respect and courtesy with all colleagues and clients. Shows appreciation to cross-functional colleagues for successful collaboration and honoring client's commitments.

• Works to build trusting and collaborative relationships throughout the organization.

• Demonstrated capacity to adapt to operational and organizational changes.

Experience:

• Bachelor's Degree required (with concentration in life sciences is preferred).

• 4-6 years of Project Management experience.

• Proven track record of successfully managing clinical drug manufacturing.

• Pharmaceutical industry and/or Medical Device experience, with knowledge of fill/finish and lyophilization a plus.

• Previous experience in a customer service or customer facing role is required.

• Strong planning and organization skills

• Critical thinking and problem-solving skills

• Good written and verbal communication skills

• Ability to resolve conflicting situations by maintaining high ethics and values

• Strong interpersonal skills

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