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Evidence Delivery Manager

Wilmington, Delaware
Evidence Delivery Manager
Wilmington, Delaware 19850
$61 per hour
6-month contract


As the Evidence Delivery Manager, you will lead/support the operational planning, delivery, oversight and budget management of company and/or externally sponsored research. In this role you will help coordinate the efforts of extended team members.

In addition, you will support the continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and maintenance of guidance documents and training materials. 
 
Responsibilities:
  • Support and coordinate protocol development and finalization Manage Study Governance as well as all internal, study governance processes.
  • Provide input into the selection of External Service Providers (ESPs), including Clinical Research Organizations (CROs) 
  • Support strategic handover meetings and kick off meetings 
  • Help ensure project delivery within time, cost and quality 
  • Support Project team set-up and study sourcing activities 
  • Support effective collaboration with the scientific/medical counterpart, the Epidemiologist/Medical Affairs Leader (MAL) respectively, as well as other internal cross functional global roles 
  • Report study updates for areas of responsibility from a time, cost and quality perspective to internal stakeholders.
  • Coordinate efforts/input of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during project design and delivery 
  • Develop and maintain the overall study budget (internal and external study costs) 
  • Work with procurement on project agreement and manage subsequent out of scope changes.
  • Manage and reconcile Contracts, POs and invoices
  • Supports the review of ESR proposals and protocols to enable a consistent, high quality approach to evaluation 
  • Manage across a range of global and local cross-functional stakeholders to ensure all obligations and responsibilities are met 
Qualifications:
  • 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 
  • Extensive knowledge of early and late stage Pharmaceutical Development 
  • Ability to effectively work with Clinical Research Organizations/External Providers. 
  • Proven ability to interact widely and effectively within the company across regions, functions and cultures. 
  • Experience and knowledge within compliant management of Externally Sponsored Scientific Research 
  • Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment 
  • Open to periods of travel
     
Please submit your resume for consideration!
#ZR
 
 
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