Professional Documents
Culture Documents
Raeesa Potnis
University of the Cumberlands
8/5/2021
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Interview with the Manager of Clinical Operations:
managing all the clinical trials in Phases 1 through 3 for the primary drug candidate at the
company. Clinical trials are a type of research that studies new tests and treatments and evaluates
their effects on human health outcomes. These trials must be carefully designed and executed
with multiple centers across the country so that data can be collected for the lead drug candidate.
These data are compiled and eventually support a marketing application with the FDA. For the
purpose of this brief, the project closure steps for a clinical trial that may be undertaken are
described below. Project closure activities ensure the recording project documents, archiving in
organizational process assets, making final payments, releasing resources and completing the
project.
1. Confirm completion of all work and that all deliverables are achieved- This includes
double checking that all the deliverables are met for the project. This step also
includes formal sign off as applicable from stakeholders to affirm that the project is
2. Reviewing contracts – Once the above step is completed, the manager can start
closing out contracts. The manager reviews all the project documentation to ensure all
parties have been paid for the work and there are no outstanding invoices. This
includes completing any remaining payments that need to be made to the vendors or
3. Performance Reporting- The final project performance can be measured using project
performance tools against the pre-defined project baselines for cost, timeline,
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4. Indexing and archival of records and documentation – Collected documentation and
data is finalized. The data is analyzed as defined in the plans for statistical analysis.
The documents must be filed properly for archival and audits must be conducted for
documentation completeness.
5. Conduct Lessons Learned and update any learnings - Lessons learned are the last
outcome of a project. The best practices applied during the project are recorded in the
lessons learned along with mistakes made over the course of the project.
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References
Larson, E., & Gray, C. (2011). PROJECT MANAGEMENT: THE MANAGERIAL PROCESS, 5th Edition. New
York, NY: McGraw-Hill/Irwin.