Associate Clinical Project Manager

Position Description

Position Summary

The Associate Clinical Project Manager is responsible for working with clients and assuring the provision of clinical trial supplies by interpreting protocol specifications and developing, integrating, and implementing materials and procedures that meet study requirements.

Position Reports to

Vice President, Global Programs

Position Supervises


Essential Duties and Responsibilities

The essential functions include, but are not limited to, the following:

  1. Work with the PM in initial study discussions with client regarding packaging designs and issues
  2. Work with the PM to ensure the accuracy as to all calculations relative to strength and appropriateness of components, correctness of proportions and other details
  3. Work with the PM in the interpretation and preparation of preliminary layout drawings and packaging samples in compliance with protocol for final clinical trial kit detail and design
  4. Assist with providing Dash-X access to clients
  5. Update original timelines using Microsoft Project or other format as requested by CPM
  6. Work with the PM on the randomization approval process, including the processing of randomization codes for use in the Xerimis labeling system and assuring that clients have approved all necessary randomizations
  7. Upload randomization list to ICS
  8. Proof randomization lists
  9. Coordinate with PM to acquire materials for use in clinical studies, including blister cards, cartons, labels, bottles, closures, film, foil, cotton, comparator products, etc.
  10. Obtain quotes for ancillary kits, drug product, and reorders
  11. Create material specifications on incoming goods
  12. Create mock up kits and packaging samples under the direction of the project manager
  13. Work with the PM on label text approval process by assuring that clients have approved all necessary text approvals
  14. Check label text against client documentation prior to client approval
  15. Create check lists for batch records under the supervision of a PM
  16. Create previously established or resupply batch records
  17. Assemble the appropriate forms into a batch record
  18. Assist with disposition process and acquire client’s signoff for destruction of bulk or finished goods.
  19. Track change orders and proposals  to ensure all invoices are considered prior to creating a new CO.
  20.  Update core CSPLs
  21. Provide inventory reports if required
  22. Interact with clients as needed
  23. Participate in client meetings as needed
  24. Function as back-up for Clinical Project Manager
  25. Provided there is sufficient experience, and with CPM oversight, take the lead on smaller clients
  26. Provide training to new employees
  27. Other duties as assigned.

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree or equivalent work experience
  • Strong project management skills
  • Excellent reading and writing skills
  • Excellent communication skills
  • Strong problem solving skills
  • English literacy
  • Excellent mathematical skills
  • Computer literacy skills
  • Attention to detail
  • Familiarity with cGMPs
  • Familiarity with the pharmaceutical industry

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.


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.

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