Project Manager, Ctd

3 weeks ago

Mississauga, Canada Marken Full time

**Title**:
Project Manager, CTD

**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 clinical supply and/or patient centric services 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 but not limited to the following scope:

- Patient Centric Services (e.g. Home Healthcare (HHC) visits, Direct-to/from-Patient (DTP/DFP) shipments).
- Storage and Distribution of supplies (ancillaries as well as medicinal products, such as Investigational Medicinal Product (IMP), Non
- Investigational Medicinal Product (NIMP), Active Pharmaceutical Ingredients (API), Standard of Care (SoC) Commercial Product, Product(s) for Named Patient Programs (NPPs)) to investigator sites, local and regional depots, HHC providers and clinical trial participants.
- Expanded Access Programs.
- 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 study deliverables are maintained in accordance with study contracts. Project activities among others encompass the support of project strategy and feasibility discussions, the creation of a Project Management Plan between Marken and its clients, development of additional project related internal and external forms and work instructions, training of Marken and external project stakeholders, setup of involved system (e.g. Marken inventory, track & trace or Home Health Care system), tracking of project activities and milestones, support with Quality incidents.
- Other responsibilities include dealing with project enquiries, preparation and maintenance of study reports and KPIs, supporting change order processing and project billing activities, assisting in client audits, developing SOPs and project forecasting.
- 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, and the similar which will improve the department, and Marken, over time**.**

**Requirements**:

- Sound knowledge of local and global Clinical Trials Regulations
- Good Manufacturing Practice (GMP)
- Good Distribution Practice (GDP)
- 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 clinical research/pharma related industry

**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.

**Moving Our World Forward by Delivering What Matters.**

EEO & Veteran Employer

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