What is Clinical Operations?

What is ClinOps?

In Clinical Operations, a clinical project team contributes to and supports a organization’s research and development program in order to advance new investigational drugs/devices to commercialization.

ClinOps delivers an inspection-ready dataset and complete documentation of the clinical activities that can support an NDA/PMA.

Core Competencies in a Clinical Operations Professional

A background as a Study Coordinator or Clinical Research Associate is a bonus when performing the ClinOps trial management role. Here are some other skills to equip you for the role of ClinOps:

  • High attention to detail and strong organization skills
  • Excellent working knowledge of ethics and regulations governing the industry
  • Collaborative problem-solving skills
ClinOps skillset combines planning + project management + study oversight

ClinOps skillset combines planning + project management + study oversight

Teamwork and Planning in Clinical Operations

A ClinOps professional works with others in the study team to ensure timely execution of all study deliverables as follows:

  • Internal Stakeholder Management – managing timelines with cross-functional teams
  • Identifying, selecting, starting up, and managing clinical trial sites
  • Developing protocol, ICF, study level training documents/manuals (in collaboration with key stakeholders like clinical research, regulatory, drug safety)
  • Providing input to systems build at study set up (such as EDC, IWRS, CTMS, eTMF etc.)

Execution and Project Management

Through adhering to guidelines and regulations, a ClinOps professional performs project management in the following areas of oversight in Clinical Operations

  • External Stakeholder management – CRO and vendors selection plus management through study milestones
  • Collaborating – maintain positive relationship with investigative sites, discuss and mitigate enrollment challenges and celebrate achievements
  • Informing – prepare global study communications (updates and status to investigative teams)
  • Training – clinical team training (initial & ongoing) plus developing training materials
  • Logistics – managing supply of trial materials including investigational product, lab kits, imaging supplies etc.
  • Authoring – contribute to clinical study reports, safety reports, publications, investigator brochures, and presentations

Oversight of Clinical Operations

  • Identifying study risks and communicate to project team and upper management and/or partners
  • Measuring enrollment and accruals of study patients
  • Reviewing – maintaining an accurate and complete record of trial activities in a Trial Master File that can be used to reconstruct the study activities
  • Fiscal Management – overseeing clinical trial budget, check that vendors are performing tasks according to scope of work
  • Analytics – operational metrics & data review

Learn More abut Clinical Operations

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About The Author

Herman Liu

Herman Liu is a Clinical Trial Management Associate at Gilead Sciences Inc. Herman completed his undergraduate studies in Biochemistry and Molecular Biology at University California, Davis. Herman also holds a professional certificate in Clinical Research Conduct and Management from UC Berkeley Extension. He started in the biotechnology industry in production, and is now in clinical operations overseeing various aspects of clinical trials. Herman is motivated by his impact on his community and beyond. Outside of work, Herman is a photography enthusiast, and an aspiring cook. Herman has been a member of ClinOps Toolkit since July 2015.

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