When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Clintrak Clinical Labeling Services LLC, part of Thermo Fisher Scientific, is the recognized leader in innovative labeling, quality and service. No company better understands your need for error-free products delivered on time, every time. Our vision is to leverage our expertise and global reach to offer a clinical labeling model that integrates regulatory, packaging and clinical logistics capabilities to deliver improved timelines and more accurate allocation of clinical trial materials. To achieve this mission, our expert staff applies years of pharmaceutical and printing industry experience. http://www.clintrak.com/
- Applies Good Manufacturing Principles in all areas of responsibility.
- Demonstrates and promotes the company vision.
- Works with the Client to finalize Specifications. This may include meetings at the client’s premises.
- Assists in setting up and maintaining study filing systems and maintains accurate records for all work undertaken.
- Joint responsibility with the Project Manager for ensuring that all business activities come together in a timely manner to meet the customer and study requirements.
- Coordination and communication of all relevant activities, both internal and external to ensure that all services and products are ready for the start of the study or as required by the customer.
- Use of appropriate project planning tools to communicate milestones and critical path activities and responsibilities.
- Timely provision of reports and other information to customers if applicable.
- Works with the Master Production Scheduler to optimize production of clinical supplies balancing the customer requirements with best use of available capacity.
- Creates and/ or supports creation of batch documentation, operational documents using internal systems. This is inclusive of billing package review.
- Provides back-up support to the Project manager, including financial and quote forecasting.
- Monitors project activities and day to day business as well as establishment of a customer approved Job Specification.
- Collects all the information on a study design including correct label texts, coordination of primary, secondary packaging material and tools, coordination of label translation and producing all batch documentation for operations and check of documentation.
- Coordinates shipments through the logistics department
- Requires accredited college, university or recognized professional degree, preferably in a health related field.
- Requires 2-3 years of successful experience in project management as a Project Coordinator.
- Requires strong interpersonal and communication skills to include excellent relationship building.
- Requires proficiency in personal computer applications (e.g. Microsoft Word, Excel, PowerPoint, Access, Outlook).
- Requires proven experience with customers in a dynamic environment.
- Requires excellent communication, organizational skills and project co-ordination skills.
- Requires understanding and competent use of SOPs required by company Quality standards.
- Requires excellent organizational, planning, verbal, written and numerical skills with the ability to analyze and define solutions and manage multiple tasks to meet strict deadlines.
- Requires strong and effective communicator with the ability to effectively present information and respond to questions from groups of managers and clients.
- Requires ability to develop strong customer management skills; proactively anticipates, understands, and responds to the needs of clients to meet or exceed their expectations.
- Requires ability to learn and master all internal systems associated with projects (i.e. DPS, Label Spec and Client Spec Applications, Randomization Parameters GPMS, Trackwise).
- Must be able to use a computer up to 8 hours per day.
- 10 - 25% Travel as needed.
- Prefer proficiency in appropriate project planning tools e.g. Microsoft Project to communicate milestones and critical path activities and responsibilities.
- Prefer in depth understanding of clinical trials.
- Prefer basic understanding of Project Management concepts.
- Prefer Certification in Project Management by a recognized institution in project management.
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. Apply today at http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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