Kit Design Specialist

LabConnect•Johnson City, TN

3d•Onsite

About The Position

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions. The Clinical Trial Material Planning Specialist is responsible for creating from project scope, pricing and versioning all Bill of Materials for kit construction. The position is the liaison between Finance, Project Management, and the Supply teams.

Requirements

Bachelor's degree from four-year college or university (preferred) or equivalent work experience.
Candidates with High School Diploma/GED with 3 years’ experience in a regulated environment.
Candidates with 3 years’ experience within a regulated environment preferred.
Knowledge of ERP systems.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.
Ability to speak effectively before groups of customers or employees of organization.
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
Ability to apply concepts of basic algebra and geometry.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
Ability to deal with problems involving several concrete variables in standardized situations.
Working knowledge of Microsoft Office applications including word processing and spreadsheets.

Responsibilities

Creating and Maintaining new Item Cards and Bill of Materials.
Ensure item card is properly mapped to budget planning line items.
Communicate with Clinical Trial Materials to ensure work instructions are complete and thorough.
Assist Project Management teams to ensure Bill of Materials are created according to trial needs.
Maintain version control on all BOM modifications and amendments.
Work with inventory team to standardize SKU’s on BOM’s.
Communicate with Supply team, Logistics and Project Management to ensure correct materials are used for international shipments.
Execute corporate pricing strategy and submitting pricing for approval.
Submit approved pricing to project management for sponsor approval
Properly file and maintain pricing calculations for future review.
Attend Project Management study kick off and handoff meetings.
Support adhoc requests from other department: Finance, BOS, Contracts
Perform various reporting as needed.