W81XWH-17-R-0074_Attch_5-Estimated_LOE_R2.xlsx

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Regulatory, Clinical and Technical (RCT) Support Services for the U. S. Army Medical Materiel Development Activity
Solicitation number
W81XWH-17-R-0074
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Revision 2 to Attachment 5 - Estimated Level of Effort

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W81XWH-17-R-0074-0003-Tracked_Changes.docx DOCX document
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W81XWH-17-R-0074_Attch_1-OCI_Certification_R1.docx DOCX document
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W81XWH-17-R-0074_Attch_5-Est_Level_of_Effort.pdf PDF
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W81XWH-17-R-0074_Attch_3-Past_Performance_Questionnaire.docx DOCX document
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Sheet1

The Government estimates that this contract will require an approximate level of effort, as outlined below, to accomplish the tasks identified in the PWS. Please note that the Government estimate is only put in place for Offerors to ascertain the approximate or estimated level of effort for this contract. However, this is not to be construed as either mandatory or necessarily the best technical approach. It is only in place as a reference to allow Offerors to better understand the general scope of this effort from the Government’s perspective. The Government is seeking the best level of effort and labor mix that the Offeror has determined is right to accomplish the mission contained in this task statement. The Offeror is not bound to propose these labor categories or quantities below; rather, it is expected to provide its best solution citing the labor mix and quantity required to accomplish the tasks. If the Offeror has determined either the following labor categories or overall level of effort provided are not the best technical solution, it is strongly encouraged and expected to submit a level of effort consistent with all of the cost/price and non-cost/price aspects of the Offeror’s approach.
Due to limited government space some contractors shall work offsited as noted. Unless otherwise stated, place of performance is government site 100% of time.
Estimated Number of ContractorsPWS ReferenceUSAMMDA Org Chart Position TitleKey PersonnelOffsiteOnsite
Onsite
16.1.1Lead Senior Regulatory Affairs Scientist
36.1.1Senior Regulatory Affairs Scientist
56.1.1Regulatory Affairs Scientist
26.1.2.1Senior Medical Writers
16.1.2.1Medical Writer (Editor)
16.1.2.3Publishing Specialist
26.1.2.2Senior QA/QC Document Control
26.1.2.2QA/QC Document Control
16.1.3Safety Pharmacovigilance Lead Support
16.1.4Safety Surveillance Support75%25%
16.1.5Pharmacovigilence PhysicianY
16.1.6.1Senior Clinical Research Associate Lead
26.1.6.1Senior Clinical Research Associate
16.1.6.2Clinical Trail Manager Lead
46.1.6.2Clinical Trial Manager
16.1.7Data Manager (CDM) Lead
26.1.7Data Manager (CDM)Y, 100%
16.1.7Data SpecialistY, 100%
16.1.7Clinical Database Developer Lead
16.1.7Clinical Database DeveloperY, 100%
16.1.7Medical CoderY, 100%
16.1.8.1Biostatistician Validation Coordinator Lead75%25%
26.1.8.2BiostatisticianY, 100%
16.8.3Statistical ProgrammerY, 100%
16.1.9Product Technical Scientist Lead
46.1.9Product Technical Scientist
0.56.1.9Manufacturing SMEY, 50%
44.5Total Estimated LOE

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