Senior Manager of Clinical Study Operations

7 days ago

Ottawa, Ontario, Canada Apmc Moving & Delivery Llc Full time

About the Role:

The Associate Director of Evidence Delivery will be responsible for the operational delivery of global strategic studies required to generate the evidence to build the confidence on company therapies and additional observational, interventional and externally sponsored research required by Global Product Teams and Global Medical Teams.

Key Responsibilities:

  • Manage Study Governance
  • External Service Provider Management
  • Perform CRO oversight to help ensure project delivery within time, cost and quality
  • Support delivery of projects to agreed timelines (scorecard), within the approved budget and according to company quality standards
  • Support global oversight over the operational study start up, implementation and closure and ensure inspection-readiness

Requirements:

  • Bachelor's degree required preferably in medical or biological science or equivalent by experience
  • Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area
  • Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools
  • Scientific awareness and extensive knowledge of observational study guidelines and SOPs

About Apmc Moving & Delivery Llc:

Apmc Moving & Delivery Llc is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our cores values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization.

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