Clinical Operations & Project Management

Clinical Operations have a lot of interaction with people in a range of other departments including Clinical Science, Clinical Quality Assurance, Data Management, Biostatistics and Regulatory Affairs to ensure that the data and information needed by these other departments is delivered so they can decide if a trial has been successful. The Clinical Operations function of a company is key to the delivery of clinical trials. Without this team no Clinical Research activity could be delivered. Clinical Operations teams are responsible for designing, planning and physically running Phase I – IV clinical trials. Many larger pharmaceutical companies have also looked at setting up strategic partnerships with Clinical Research Organizations to outsource some or all of their Clinical Operations activities.

Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms. Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.

 

  • Early clinical development: Operational strategies
  • Misconduct and fraud in clinical trials
  • Managing risk with contracts: Informed consent, Subject injury, Insurance & Indemnification
  • Integrating quality into clinical trials
  • Risk-Based monitoring
  • Setting & managing priorities in a clinical project schedule
  • Clinical trial project management platforms
  • Translation of clinical trial documents – challenges, options and solution
  • Streamlining R&D clinical trials operations
  • Transforming clinical development
  • Good clinical practice and inspection readiness

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