Clinical Trial Department - Project Management Specialist

The main purpose of the Project Management Specialist role is the overall responsibilit for the successful planning, execution, monitoring, control and closure of clinical supply and/or patient centric services projects.

Main Duties and Responsibilities

1. 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

2. 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.

3. 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.

4. 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.

5. 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.

General  

To adhere to all company Policies always.

To undertake any other reasonable duties at the request of the Line Manager.

Ensure compliance with national and international standards and legislation

Travel as reasonably requested by the Line Manager for the performance of duties.