Associate Clinical Project Manager - Clinical Trial Materials

Our Client is an independently owned and operated company that works exclusively with clinical trial materials. The UK site provides secondary packaging, labelling and distribution of clinical trial supplies for sponsor company organisations. Their facility near Reading serves as the packaging and distribution hub for clinical trial materials to Europe and the rest of world.

Due to continued growth, they are now seeking an Associate Clinical Project Manager to join their dynamic team. This position is a full-time permanent role and will be based near Reading, Berkshire.

Job Purpose

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

Key Areas of Responsibility

• Work with the PM in initial study discussions with client regarding packaging designs and issues
• 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
• 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
• Assist with providing Dash-X access to clients
• Update original timelines using Microsoft Project or other format as requested by CPM
• Work with the PM on the randomization approval process, including the processing of randomization codes for use in the labeling system and assuring that clients have approved all necessary randomizations
• Upload randomization list to ICS
• Proof randomization lists
• Coordinate with 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 ancillary kits, drug product, and reorders
• Create material specifications on incoming goods
• Create mock up kits and packaging samples under the direction of the project manager
• Work with the PM on label text approval process by assuring that clients have approved all necessary text approvals
• Check label text against client documentation prior to client approval
• Create check lists for batch records under the supervision of a PM
• Create previously established or resupply batch records
• Assemble the appropriate forms into a batch record
• Assist with disposition process and acquire client's signoff for destruction of bulk or finished goods.
• Track change orders and proposals to ensure all invoices are considered prior to creating a new CO.
• Update core CSPLs
• Provide inventory reports if required
• Interact with clients as needed
• Participate in client meetings as needed
• Function as back-up for Clinical Project Manager
• Provided there is sufficient experience, and with CPM oversight, take the lead on smaller clients

Qualifications and Experience

• Bachelor s degree or equivalent work experience
• Familiarity with cGMP
• Familiarity with the pharmaceutical industry
• 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

In return our client is offering a basic salary of GBP28,000 - GBP30,000 per annum basic plus benefits for the successful Candidate. Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.