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Project Manager-III
Ref No.: 18-05649
Location: Horsham, Pennsylvania
Position Type:Clinical
Start Date / End Date: 04/23/2018 to 12/31/2018
Job Title: Project Manager-III
Duration: 7 months
Location: Horsham, PA- 19044

Job Description:
 
Project Manager – European Union Clinical Trial Regulation
  • Pharmaceutical client is working to implement a process to ensure compliance with the European Union Clinical Trial Regulation (EU CTR).
  • Although the Regulation entered into force on 16 June 2014 the timing of its application depends on the development of a fully functional EU clinical trials portal and database, which will be confirmed by an independent audit.
  • The Regulation becomes applicable six months after the European Commission publishes a notice of this confirmation.
  • The entry into application of the Regulation is currently estimated to occur in 2019.
  • The Regulation will ensure a greater level of harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements.
  • It will also make it easier for pharmaceutical companies to conduct multinational clinical trials, which should increase the number of studies conducted within the EU.
 Key benefits of the Regulation:
  • Harmonised electronic submission and assessment process for clinical trials conducted in multiple Member States
  • Improved collaboration, information-sharing and decision-making between and within Member States
  • Increased transparency of information on clinical trials
  • Highest standards of safety for all participants in EU clinical trials
  • Project Management support is required to ensure timely execution of the Global Medical Organization (GMO) – Safety Management implementation plan to meet compliance with EU CTR as well as alignment with a Procedural Document Enhancement (PDE) Initiative.
 
The Safety management Workstream has a charter with Key deliverables. Project Management support is required for the following areas:
 
  • Manage the overall process implementation to ensure holistic and cohesive approach to EU CTR changes within GMO documented processes (e.g. SOPs, Work instructions) in alignment with PDE philosophies.
  • Drive consensus and decision-making with business lines, senior/functional area management, external GMSO stakeholders and IT as applicable
  • Drive timely development of key deliverables by planning and facilitating productive working sessions to create deliverables; share perspectives; push the thinking to create robust deliverables, suggest improvements, and connect the dots.
  • Finalize end-to-end process maps for procedural changes
  • Independently monitors and manages the project progress, project plan and resources identifying efficiencies and improvements while maintaining high quality standards.
  • Ensure that outstanding project management, process implementation and design requirements and/or issues are being addressed
  • Independently monitor and manage the project progress, project plan and resources identifying efficiencies and improvements while maintaining high quality standards.
 Project Management/Communications:
  • Provide direction to the project teams for deliverables due as well as the overall status of the project
  • Maintain an overall integrated project plan and communicate key interdependencies across functions within workstream.
  • Maintain visibility on day-to-day activities with project teams
  • Provide status reporting to internal and external stakeholders on a regular basis
  • Lead the development of internal/external stakeholder communications as requested.
  • Assist with all aspects of project/team meetings, including scheduling, facilitating, reporting, minute taking, etc. and participate in the preparation of materials for presentation to department leadership on progress of project, issues, mitigations strategies, etc.
  • Distribute meeting minutes and track actions to closure
  • Collate routine dashboard updates/presentations for core team meetings as well as support the development of presentations for Steering Committee and Leadership meetings
  • Support maintenance of project content in SharePoint
  • Provide project Management support to PDE initiative as applicable
 Coordinate or Lead project documentation activities:
  • Documentation of project requirements, objectives and plans, technical documents, storyboards, etc.
  • Partner with Operational Performance personnel to ensure archival and retrieval of documentation from an inspection readiness perspective
 Key Deliverables
  • Revision of ~40 procedural documents to support EU CTR
  • Go-live implementation Mid-2019
 Qualifications
  • PMP certified Project Manager is preferred
  • Experience in Pharmacovigilance, Clinical Profession or allied field with business planning and operational experience in a multi-functional organization preferred.
  • Experience with program management and coordination of multi workstreams
  • Minimum of Bachelor degree in life sciences with 3 years pharmaceutical experience; understanding of GXP requirements
  • Strong presentation, communication, interpersonal skills required
  • Detail oriented, performance driven, strong decision-making skills
  • Ability to function in a global matrix environment
  • Proven experience developing presentation materials for an executive audience
  • Proficiency with MS Office 365 (PowerPoint, Excel, Word, and Visio)
 

Apply on-line for immediate consideration, please send your updated resume and contact info via
 Contact: Rashmi M
Email: rashmi@sunrisesys.com | Phone: 732 272 0331