The 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
Essential Duties and Responsibilities
The essential functions include, but are not limited to, the following:
- Interact with proposal manager during the proposal writing phase regarding study design and specifications. This includes CSPL information gathering and capture.
- Responsible for accuracy as to all calculations relative to strength and appropriateness of components, correctness of proportions, etc.
- Interact directly with client to determine specific requirements of each packaging operation. Provide input to CSPL/Global PM in more complex global situations.
- Communicate with IT to assign DASH-X access to clients as needed
- Create and maintain timelines using Microsoft Project or other format
- Perform randomization approval process, including the outsourcing of randomization codes, the processing of randomization codes for use in the Xerimis labeling system and assuring that clients have approved all necessary randomizations
- Act as liaison between Operations and QA in further defining requirements for packaging activity.
- Coordinate with Associate PM to acquire materials for use in clinical studies, including blister cards, cartons, labels, bottles, closures, film, foil, cotton, comparator products, etc.
- Obtain quotes for component labels and cartons, items involved in the design of the kits.
- Create material specifications on incoming goods
- Acts as point of contact for all incoming material related to packaging.
- Act as liaison between client and all internal departments for requisition of required documentation (Certificate of Analysis, MSDS, client authorization etc).
- Initiate and develop all new card designs.
- Create mock-up kits and packaging samples
- Oversee label text approval process, including the creation of text within the Xerimis label printing system, assuring that clients have approved all necessary text, and incorporating expiry date and manufacture lot strategy established for the study approvals.
- Create/oversee English label text (when requested by client).
- With guidance of GPM, oversee the designing of booklet labels when in-house design is necessary.
- Perform batch record process including creation of initial packaging sample.
- Responsible for training/instructing personnel on creating batch records.
- Supervise and communicate with outside vendors regarding sub-contracted services.
- Coordinate activities between internal departments and client, either independently or in collaboration with GPM if global has been assigned to the project.
- Provide input to GPM to coordinate packaging and or distribution in the EU for supplies moving from INC to LTD.
- Collaborate with all departments to meet client timelines.
- Responsible for final signoff on the destruction of clinical labels, and acquire client signoff
- Communicate change orders to Proposals and include in CSPL appendices.
- Work with Finance on invoice issues
- Participate in client and/or health authority audits.
- Populate PIF-POF and obtain client signature
- EU and UK CPMs track and advise QP regarding incoming manufacturing lots
- EU and UK CPMs track and advise QP regarding new Packaging runs / BRs
- Work with Xerimis Ltd QPs to ensure materials entering the EU are suitable for use and documents are available; either independently or in collaboration with GPM if global has been assigned to the project.
- Generation and upkeep of pertinent sections of CSPL with the understanding that this is a jointly owned document requiring input from all departments.
- Manage and document client meetings
- Other duties as assigned
Minimum Qualifications (Knowledge, Skills, and Abilities)
- Bachelor’s degree or equivalent work experience
- Excellent project management skills
- Excellent reading and writing skills
- Excellent communication skills
- Excellent 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.