Study Coordinator - Kit Production in Berlin bei Precision Medicine Group

Precision for Medicine develops assays and run global logistics using biomarkers to stratify patients, incomparably improving client's R&D efficiency and success. We handle every aspect of clinical trials from sites to biomarkers to diagnostics. Precision Medicine Group, LLC is the leading global provider of precision medicine research services and creative commercialization solutions for life sciences companies.

We are unusually positioned for continued growth as we expand the company's global footprint and develop leadership in the most creative areas of life sciences as we help our clients develop and deliver lifesaving medical treatments to patients across the world.

Due to continued growth, we are currently seeking a Study Coordinator, Kit Production. The successful candidate will manage the process of creating, auditing, and approving Kit Production related documents to support Global Research Studies.

Essential functions of the job include but are not limited to:

• Work collaboratively with the Project Management Team to support the creation of Study Specific Laboratory Instruction Manuals or Flowcharts
• Act as the Subject Matter Expert (SME) and fully understand the Laboratory Manual/Flowchart in order to create Study Specific Documents
• Create and Audit Kitting Documents which may include Checklists, Requisition Forms, Packing List, Commercial Invoices, Inventory Supply Forms, Kit Label Files and the Laboratory Manual
• Amend and update documents as required with authorization of the Project Manager
• Participate in Client calls as an Observer, as necessary

Other Duties include

• Work closely with the Receiving Team to facilitate the Raw Materials Process to bring supplies into Production for the use in Kits
• Lead all efforts for Kit Production Inventory Management
• Support Periodic Review of Kit Production documents through our Quality Management Process
• Generate and track established Key Performance Metrics for Kit Production
• Other duties as assigned

Qualifications:

Minimum Required:

• Associates Degree or equivalent combination of education and experience
• 2 years of lab/repository experience with government contracts, commercial services or in product development

Other Required:

• Must have excellent organizational skills with the ability to manage multiple tasks and interact effectively with multiple departments and levels internally as well as externally
• Ability to work under pressure, multi-task at a high level and meet tight deadlines; exercise judgment within generally defined practices and policies; work independently and take initiative
• Must possess strong computer and business writing skills
• Experience with Microsoft Office
• Excellent communication, interpersonal, organizational and multi-tasking skills required
• Excellent use of judgment and discretion
• Professional and mature emphasis on Client Service and project delivery
• Possess proven track record of being a team player, willing to interact proactively and productively at times independent of the Project Manager
• Ability to communicate with personnel across diverse technical and business backgrounds both internally and externally
• Ability to assume additional Duties as necessary to enhance the contributions of this role
• Must be able to read, write, speak fluently and comprehend the English language

Preferred:

• Bachelor's Degree