Sr. / Project Manager, CTD
3 weeks ago
Description
Title:
Sr./ Project Manager, CTD
Job Purpose:
The main purpose of the Senior 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 Senior Project Manager is acting as a mentor for a team of Project Managers and Project Specialists or Coordinators and Project Admins by providing On-the-Job Training and general guidance to their peers as requested by the Team Lead. The Senior Project Manager does not have line management responsibilities but may provide feedback about performance of team members to the Team Lead. The Senior Project Manager in the mentoring role will contribute to overall process improvements by actively helping in identifying process gaps, updating SOPs and developing training materials. The Senior Project Manager will maintain their full responsibility as Project Manager, which includes but is not limited to the following project related activities:The role is highly people oriented and entails dealing directly with clients and internal operational departments for setup and implementation of (global) 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 participantsExpanded 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 Senior 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, supporting the development/revision of SOPs and project forecasting. Outside of client project support, the Senior 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) Extended knowledge about clinical trial supply systems and processes (inventory systems and IVRS), processes for manufacturing of clinical supplies especially labeling, packaging and randomization 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 3 years project management experience, ideally in a clinical trials environment Experience in global project management Graduation e.g., in Life Sciences or Logistics or other supply chain related industry or > 2 years professional experience in clinical research/pharma related industrMarken 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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