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Cost Management Plan for Clinical Operation Department

Paper Type: Free Assignment Study Level: University / Undergraduate
Wordcount: 2602 words Published: 19th Oct 2020

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The intent of this Cost Management plan shall be to establish the methods in which the expense affiliated with the Clinical Operations Department project will be handled during the lifecycle of the project. This plan will set forth the requirements and steps by which the project will be assessed and measured, controlled, and reported, to confirm that said project is completed successfully according to the budget allotted. Cost components of this project, metrics, reporting activities, and variances in cost shall be outlined within this plan. Stakeholders and all principle project personnel shall comply with the guidelines according to the Cost Management Plan and the project plan, to successfully complete this project.

Outlined in this plan are:

  • Guidelines to manage cost
  • Determination of the project expense, budget, and funding
  • Responsibility and authority for cost management, project change request approval, and project funds and budget
  • Quantitative measures, cost performance reporting methodologies used
  • Reporting format identification and recurrence, and to whom they will be delivered

Management of Project Cost

The Clinical Operation Department project will require the resources for the project establish and manage the overall ownership expense of the project, which will include a budget estimate, and comparison of all actual spending to the budget for the following:

  • Resources and consultants external to the organization
  • eTMF and EDC databases
  • External contracts
  • Vendor project team staff and associated cost

All activities and planning criteria, project cost controls, and structure will be established by this Cost Management Plan. Cost estimation and control are critical evaluation elements for this project, as the company is a start-up. Variance and actual cost shall be reported frequently to the projects sponsor and oversight committee. If there is any change in cost over 10 percent mandates approval from the steering committee for the project.

This Cost Management Plan and the expense at baseline will be created by both the Project Director and the Project Sponsor for the Clinical Operations Department project. Preliminary cost estimation will be developed and updated to work performed, including a schedule revision by the Project Director.

Cost Estimation

All methodologies used in the control and management of any internal and/or external cost shall be documented in this Plan for the Clinical Department Project. All variance analyses and metrics will be applied to the cost outlined below for the life of the project.  Cost segments include:


  • Licensure /software
  • Hardware
  • Project management /team personnel
  • Additional staff recruitment


  • Vendor contract cost
  • Vendor staff cost

The best information at the time will be used to estimate cost of the project. The approach used to detail cost estimates for project activities will be a ‘bottom-up’ approach. The cost estimate will be adjusted and documented whenever better information become available.

Budget Determination

The finalization of staffing and resource requirement that are crucial to the completion of the project by the project team, once the needs for the Clinical Operation Department project are determined. Completion of the Work Breakdown Structure (WBS) for external and internal components will be done in collaboration by both the Project Director and the Project Manager. Each WBS element will contain control accounts and staff labor categories. WBS element allocations will be compared to the budget and adjusted accordingly as required to align with the project budget, once budget approval is achieved by the Project Director. The Project Manager will review and accept all allocations, and the budget will become the budget baseline. All changes to the budget baseline will only occur after it is approved by the Project Sponsor.

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Performance & Responsibilities

Collaboration between the Senior Project Director and Project Sponsor will be necessary to establish performance and responsibilities of the resources managing the project cost. Ownership of the review and acceptance of all expenses for the project, definition of project cost, budget and daily cost details will be defined in their prospective roles within the project. Ultimately, the Director is accountable for governing all expense details and to make sure that the project is on-time and within budget.

All reporting during the monthly meetings shall be the responsibility of the Director. The Project Director is accountable for deviation in cost, and for their presentation to the Project Sponsor, Change Control Board, and Project Steering committee along with any resolution to project shortages and any overages. It is within the authority of the Project Sponsor to enact any deviations to bring the project within budget.

Measurement of Performance

The performance of project will be measured to capture the performance of the scheduling and expense for the Clinical Operations Department project. Cost Performance Index (CPI) and the Schedule Performance Index (SPI) metrices shall be relayed by the Project Manager. The following criteria shall be applied to the project:

  • CPI will be report monthly and is the EV/AC of the project
  • SPI will be report on a monthly basis and is the EV/ PV of the project
  • The points of control for both CPI and SPI are as follows:
    • Yellow: +/- 15 shall be reported to the Project Sponsor. If there are not any effects to the baseline cost, then no further action
    • Red: +/- 15% shall be reported to the Project Sponsor. Remedial actions shall be executed to advance the project within acceptable level of performance

Earned Value Metric

Frequency of Reporting






CPI<0.9 or CPI>1.4




SPI<0.9 or SPI>1.4

  • Cost Variance (CV) is the project’s (AV-EV) and will be reported monthly
  • Schedule Variance (EV) is the project’s (PV-EV) and will be reported monthly

A table shall be created for each of the aforementioned metrics on the 4th of every month and shall be presented monthly to the Sponsor.

Cost Change Control Process

If the Clinical Operations Department project exceeds CPI or SPI threshold limits, remedial action will be necessary to reign in the project into an acceptable performance range. All measures to regain control of the project will be reviewed and a detailed analysis will be presented to the Sponsor. Included in the analysis shall be:

  • A description of the control measures
  • Affected personnel
  • Implementation timeline
  • Implementation issues and/or concerns
  • Project performance implications

All items will be reviewed and approved by the Sponsor. Once approved, the Project manager can implement the authorized control measure according to the established change control process. Every effort should be made to avoid the re-baseline of project cost, but if the circumstances should arise the Project Sponsor will have to authorize this activity.

Procurement Management Plan


The guidelines set forth in this Plan shall establish the schema for procurement for the Clinical Operations Department project. This plan will serve as the procurement guideline for the project throughout the lifecycle of the project and updated as necessary changes occur. The services that will be solicited will be defined in this plan, along with the necessary contracts that will be used to back this project, the approval process to approve said contract, and the criteria for decisions will be outline in this plan. Included in this plan will be contract deliverables, procurement activities measurements, and coordination of procurement activities.

Procurement Management

Oversight and management of personnel and procurement activities associated with the procurement of services for the Clinical Operation Department project will be provided by the Project Director. In collaboration with the project team, the Project Director will identify the services to be solicited to complete the project successfully. Once all services have been identified the Project Director shall review the items for approval with the Project Steering Committee. During this time, the process will entail what outside services and support will be required, how to acquire it, when to acquire it, and how much is required for the project.

Procurement Definitions

The service that are essential for the finalization of the Clinical Operations Department project. Pending Project Steering Committee approval, the following services, timeline, and justifications will be submitted to the office of procurement:




Needed By

Item A

Electronic Trial Master File (eTMF): for archives of trial related documents


Dec 2019

Item B

Electronic Data Capture (EDC): for entering clinical trial data


Feb 2019

Item C

Vendor to set-up new system eTMF system


Jul 2019

Item D

Hosting of databases


Feb 2019

Item E

Software updates

Software Maintenance

Feb 2019

Item F

Vendor to set-up new EDC system


Feb 2019

Item G

System validation for eTMF and EDC vendor validation department

Independent Verification and Validation (IV&V)

Feb 2019

Item H

Additional staff and consultants

IT and vendor consultants

Nov. 2019


The following personnel are authorized to approve project acquisition for the project team, including the items above:

Name                               Role

Mary Pol                         Senior Project Director

Charlyse Johns                IT Manager

Jerrett Atkins                  Clinical Operation Director

Contract Type and Procurement Approval

Firm-fixed contract prices will be solicited for all services to be provided for the Clinical Operations Department project. In collaboration with Finance Department and the Procurement team the project team will outline the requirements services, delivery dates, and service types. Solicitation of bids from vendors to receive services at equitable cost under the firm price contract framework and in a reasonable timeframe will be requested by the RFP coordinator, once the vendor is selected.

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The type of procurement framework that will fit the project shall be determined by the Senior Project Director in collaboration with Finance Department. An RFI may be requested if additional information is needed as the first steps to procurement. The Finance Department in collaboration with the Procurement team will establish the process that will be followed with respect to the procurement of services. Approval of the procurement documents will made by the Finance Department.

Decision Criteria

The decision to award contracts for services during this project shall be determined by the following criteria:

  • Vendor Qualifications and staff
  • Cost of outsource service vs in-house sourcing
  • Past technical qualification and performance
  • Oral presentation and software Demo
  • Timely delivery of required items
  • Experience and qualification of vendor
  • Quality of work
  • Support team infrastructure

The final decision for vendor selection after all the criteria items has been submitted for review by the Senior Project Director, Finance Department, IT Manager, Clinical Operation Director, will be made based on the criteria above and other resources available at the time.

Vendor Management

A weekly meeting will be scheduled with the clinical project team and each vendor to converse the progress of the services under contract. During the meeting all product specifications will be reviewed and any issues in countered will be discussed. At this time all questions will be answered, and any necessary contract modification will be documented for approval to avert delays in the project time line. Accountability for vendor management fall to the Project Director, and it is their responsibility to assure timely and quality delivery of work from all vendors for this project.


Approved by:

__________________________________ Date:________________


[Subject] Executive Sponsor

__________________________________ Date:________________


[Subject] Business Sponsor

__________________________________ Date:________________


[Subject] Project Director/Manager

__________________________________ Date:________________


[Subject] Stakeholder



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