Senior Clinical Project Manager

3 weeks ago

Leeds, Leeds, United Kingdom Pharmiweb Full time
Job Title: Associate Director Clinical Project Management

You will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence. The Medical Evidence Delivery Team within the Oncology Business Unit (OBU) is responsible for strategic planning and operational delivery of interventional and observational studies, externally sponsored scientific research, and early access programs (EAP).

Key Responsibilities:
  • Lead the operational planning, delivery, oversight, and budget management of company-sponsored evidence studies and/or early access programs (EAP) within the assigned therapeutic area (TA).
  • Study-level interface with externally managed/outsourced partners for studies planning and delivery.
  • Be the primary point of contact for the CRO Project Manager to ensure study delivery according to agreed timelines, budget, and quality standards.
  • Review protocol drafts and input operational perspectives/content into document and authoring team discussions.
  • Provide input into and/or quality review and hold accountability for the development of essential study-level documents.
  • Manage/oversee financial processes (PO's, invoicing, cost reconciliation, etc.).
  • Monitor study risks throughout delivery and oversee the team in the development/implementation of mitigations and contingencies.
Requirements:
  • Bachelor's degree required, preferably in medical or biological science or equivalent by experience.
  • Experience and knowledge within compliant management of Early Access Program.
  • Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process, and relevant guidelines (e.g. GCP/ICH) for a specific therapeutic and geographical area.
  • Advanced degree in medical or biological sciences or field associated with clinical research.
  • Project Management qualification or demonstration of project management skills, including scope, budget, timeline, resource management, and use of associated tools.
  • Experience of incorporating digital health and patient-centric strategies into clinical studies.

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