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Week 14 BADM 637-Strategic Applications in Project Management

The document outlines the project closure steps for clinical trials at Frequency Therapeutics, managed by the Manager of Clinical Operations. Key activities include confirming deliverables, reviewing contracts, performance reporting, archiving records, and conducting lessons learned. These steps ensure proper documentation and closure of the clinical trial project, ultimately supporting FDA marketing applications.

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Raeesa Potnis
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39 views4 pages

Week 14 BADM 637-Strategic Applications in Project Management

The document outlines the project closure steps for clinical trials at Frequency Therapeutics, managed by the Manager of Clinical Operations. Key activities include confirming deliverables, reviewing contracts, performance reporting, archiving records, and conducting lessons learned. These steps ensure proper documentation and closure of the clinical trial project, ultimately supporting FDA marketing applications.

Uploaded by

Raeesa Potnis
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

Week 14

BADM 637- Strategic Applications in Project Management


Activity 14

Raeesa Potnis
University of the Cumberlands
8/5/2021

1
Interview with the Manager of Clinical Operations:

The Manager of Clinical Operations at Frequency Therapeutics is responsible for

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

complete. This can serve as a formal acceptance of project deliverables.

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

partners. The procurement steps can thus also complete.

3. Performance Reporting- The final project performance can be measured using project

performance tools against the pre-defined project baselines for cost, timeline,

schedule and quality.

2
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.

Documenting wrong decisions, wrong implementations, or impediments that

caused project team to deliver slower outputs can be of use for future trials.

3
References

Larson, E., & Gray, C. (2011). PROJECT MANAGEMENT: THE MANAGERIAL PROCESS, 5th Edition. New
York, NY: McGraw-Hill/Irwin.

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