Title:
Project Manager, Kit Operations (all genders)
Job Purpose:
The main purpose of the Project Manager’s role is the overall responsibility for the successful planning, execution, monitoring, control and closure of kit operation activities for clinical supply projects.
Main Duties and Responsibilities:
- The role is highly people oriented and entails dealing directly with clients and internal operational departments for setup and implementation of projects including kit and ancillary services for clinical supply projects
- The role necessitates taking ownership of the project. This involves providing the client with a primary contact point and acting as the ''project owner" to coordinate the internal operational and quality departmental roles in the project.
- The Project Manager is responsible for managing the project budget and ensuring key project deliverables are maintained and delivered on time in accordance with project contracts.
- Project activities among others encompass
- The support of project strategy and feasibility discussions
- The preparation of budget proposals for opportunities/initiatives
- The setup of kit operation projects in accordance with all relevant guidelines, legislation and SOPs including the conduction of the kick-off meeting, the creation of project specifications between Marken and its clients, development of additional project related internal and external forms and instructions, set-up of the project master file, the kit production data base, the distribution & import process, the creation of production documents and support of material procurement activities
- The maintenance of kit operation projects in accordance with all relevant guidelines, legislation and SOPs including the tracking of project activities, milestones and KPIs, maintenance of the project master file, dealing with internal and external project queries as main point of contact, support of logistic and import activities, support of billing activities, support with quality incidents
- The closure of kit operation projects in accordance with all relevant guidelines, legislation and SOPs including archiving of the project master file, gathering of client feedback
- The proactive identification and escalation of any risks to meet deliverables.
- The performance of quality control activities per the appropriate process/requirements
- The assisting in client audits
- Outside of client project support, the Project Manager is expected to be an engaged member of the Project Management team, contributing to training, business process documentation, departmental activities, budget and project forecasting, SOP development and the similar which will improve the department, and Marken, over time.
Qualifications:
- Project Management tools and techniques
- Strong project management and organizational skills.
- Proven self-management skills and ability to efficiently prioritize tasks, proactive working style
- Ability to communicate effectively with clients and manage multiple projects.
- Excellent communication and negotiation skills with fluent written and spoken English.
- Ability to manage multiple projects proactively across a multi-disciplinary team.
- Understanding of a clinical trial protocol
- Strong work ethics
- Team-oriented way of working
- Ability to adapt to changes
- Minimum of 2 years project management experience, ideally in a clinical trials environment
- Graduation e.g. in Life Sciences or Logistics or other supply chain related industry or > 2 years professional experience in project management
Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.
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