Project Manager, Clinical Supplies Packaging

Job Description

Job Description

The Clinical Project Manager is responsible for managing the packaging of clinical trial supplies. This role serves as the primary client contact for US only studies and supports Global Program Management on ex-US studies. This role is responsible for ensuring compliant execution and on-time delivery of all packaging related project milestones.

Reports to:

Director, Project Management

Supervisory Responsibility:

None

Core Responsibilities

· As project lead, act as the primary liaison for sponsors, owning all communications, decisions and deliverables for US only studies

· Support project leads on global studies, providing support on project planning, timelines, study dashboards and project documentation as required

· Coordinate with internal teams to meet project requirements, deliver consistent project execution, identify project risks and drive issue resolution

· Lead or participate in client meetings to ensure ongoing alignment on project needs

· Facilitate change order management. Notify finance on any special invoicing requirements.

· Perform randomization approval process, including the outsourcing of randomization codes and the processing of randomization codes for use in the Xerimis labeling system.

· Coordinate with packaging design on tooling and component requirements. Coordinate with label production on generation and approval of label text documentation. Order and track material acquisition and receipt.

· Write batch records ensuring inclusion of any special client requirements.

· Coordinate with Qualified Persons as required for incoming materials, new packaging design, batch record requirements and documentation as needed.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree or equivalent work experience
• 2+ years of project management experience

· Familiarity with cGMPs and the pharmaceutical industry

· Excellent communication, relationship management and problem-solving skills

· Strong attention to detail with a quality mindset

· Proficiency in Microsoft Office and project management software

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this job, the employee is regularly required to talk or hear. While performing the duties of this job, the employee is exposed to an office environment and may be exposed to the warehouse and operations (packaging) environment including occasional exposure to elements such as odor, noise, dust, heat, cold or chemicals. The noise level in the work environment is usually moderate.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.