Late Phase Project Manager

hace 6 días

Madrid Centro, Madrid, España Importante empresa A tiempo completo
About the Role

We are seeking a highly skilled and experienced Senior Project Manager to join our team at Importante Empresa. As a key member of our organization, you will be responsible for managing Real World Late Phase projects across functional areas and assigned project team members.

Key Responsibilities
  1. Project Leadership and Delivery
  • Manage one or more Real World Late Phase studies, ensuring compliance with Good Clinical, Pharmacovigilance and Pharmacoepidemiology Practices (GCP, GVP and GPPs) together with relevant Standard Operating Procedures (SOPs), regulatory guidelines and requirements as applicable.
  • Act as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer's and the Company's contractual agreement.
  • Coordinate a multi-disciplinary functional team to ensure deliverables, quality, timelines, and budget management.
  • Accountable for the financial performance of assigned projects.
  • Accountable for all project deliverables for assigned projects and/or project regions.
  • Coordinate activities and deliverables of all project conduct partners and proactively identifies and manages issues.
Reporting and Communication
  • Accountable for maintenance of project information on appropriate databases and systems.
  • Tracks and evaluates project progress by developing and implementing study specific Project Plans, timelines and other tracking/analysis tools in accordance with Controlled Documents.
  • Responsible for project management components of inspection readiness for all aspects of the project conduct, including Project/Trial Master Files.
  • Independently prepares, coordinates, and presents project material at internal and external meetings.
  • Prepares project management reports for clients and management, including detailed project timelines.
  • Implements resource strategies to achieve project goals.
  • Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals.
Business Development
  • Participates in bid defense meetings and contributes to new business development.
  • Develops and maintains strong relationships with clients to generate new and/or add-on future business.
Management
  • Support new Project Managers, facilitates team training in accordance with protocol and/or project requirements, including design, therapeutic, protocol specific, and process training.
  • Directs the activities of assigned Project Support staff; may line manage/mentor other project management team members; facilitates team building and communication.
Requirements
  1. Prior experience in Real World Late Phase studies.
  2. Bachelor's Degree (or equivalent) level of qualification (life sciences, Medicine, Pharmacy, Nursing or related field preferred) or equivalent combination of education and experience.
  3. Strong knowledge of Good Clinical, Pharmacovigilance and Pharmacoepidemiology Practices.

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