W81XWH-17-R-0074_Attch_5-Est_Level_of_Effort.pdf

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.

Onsite

1 Lead Senior Regulatory Affairs Scientist 3 Senior Regulatory Affairs Scientist 5 Regulatory Affairs Scientist 2 Senior QA/QC Document Control 2 QA/QC Document Control 1 Publishing Specialist 2 Senior Medical Writers 1 Medical Writer (Editor) 1 Lead Senior Safety Specialist 1 Senior Safety Specialist 75% 25%

Safety Pharmacovigilence Physician (Infect.

Dis.)/Medical Officer

1 Lead Senior Clinical Research Associate 2 Senior Clinical Research Associate 1 Clinical Trail Manager (Lead) 4 Clinical Trial Manager 1 Statistical Programmer Y, 100% 1 Senior Biostatistician 2 Biostatistician Y, 100% 1 Lead Biostatistician Validation Coordinator 75% 25% 1 Lead Data Manager 2 Data Manager (CDM) Y, 100% 1 Data Specialist Y, 100% 1 Lead Clinical Database Developer 1 Clinical Database Developer Y, 100% 1 Medical Coder Y, 100% 1 Lead Product Technical Scientist 4 Product Technical Scientist 1 Manufacturing SME Y, 50% 46 Total Estimated LOE

# of Contractors USAMMDA Org Chart Position Title Offsite

Sheet1