Attch06TOLOE.xlsx
XLSX spreadsheet 14 KB Posted
- Solicitation number
- W81XWH21R0078
- Issued by
-
Department of the Army Medical Command
About this file
This document contains an estimated level of effort template for a federal contract opportunity to provide Regulated Activities Support Services for the U.S. Army Medical Research and Development Command Office of Regulated Activities. The government estimates that the contract will require approximately 36.5 full-time equivalents onsite and 2.5 full-time equivalents offsite to accomplish the tasks outlined in the performance work statement. Specific labor categories and estimated numbers of personnel are provided, including clinical research associates, clinical trial managers, data managers, medical writers, pharmacovigilance physicians, regulatory affairs scientists, and other positions. The solicitation number for the federal contract opportunity is W81XWH21R0078. The combined synopsis/solicitation can be found in an attached document. The contracting agency is the Department of the Army Medical Command.
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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. | ||||
| Estimated Number of FTE | Labor Category | Key Personnel | Onsite | Offsite |
| Onsite |
| 0 | Administrative Assistant I | 0 | 0 | |
| 1 | Administrative Assistant IV | 1 | 0 | |
| 0 | Assistant Project Manager | 0 | 0 | |
| 1 | Clinical Database Developer | 1 | 0 | |
| 0 | Clinical Project Manager | 0 | 0 | |
| 0 | Clinical Trial Assistant | 0 | 0 | |
| 3 | Clinical Research Associate | 3 | 0 | |
| 0 | Clinical Trial Coordinator | 0 | 0 | |
| 5 | Clinical Trial Manager | 5 | 0 | |
| 2 | Contract Task Manager | Yes | 0 | 2 |
| 0 | Data Manager | 0 | 0 | |
| 0 | Data Specialist | 0 | 0 | |
| 2 | Database Manager | 2 | 0 | |
| 1 | Document Control and Quality Specialist | 1 | 0 | |
| 1 | Financial Support Specialist | Yes | 1 | 0 |
| 1 | Medical Coder | 1 | 0 | |
| 2 | Medical Writer | 2 | 0 | |
| 1.5 | Pharmacovigilance Physician | Yes | 1 | 0.5 |
| 0.5 | Product Manufacturing Expert | 0.5 | 0 | |
| 3 | Product Technical Operations Scientist | 3 | 0 | |
| 1 | Project Manager | 1 | 0 | |
| 0 | Quality and Compliance Specialist | 0 | 0 | |
| 0 | Quality Assurance Specialist III | 0 | 0 | |
| 0 | Quality Control Manager | 0 | 0 | |
| 9 | Regulatory Affairs Scientist | 9 | 0 | |
| 0 | Regulatory Affairs Specialist | 0 | 0 | |
| 0 | Regulatory Biostatistician | 0 | 0 | |
| 0 | Regulatory Compliance Officer | 0 | 0 | |
| 0 | Pharmacovigilance Specialist | 0 | 0 | |
| 1 | Safety Surveillance Support | 1 | 0 | |
| 1 | SAS Programmer | 1 | 0 | |
| 1 | Senior Biostatistician | 1 | 0 | |
| 1 | Senior Project Manager | 1 | 0 | |
| 0 | Senior Technical Product Manager | 0 | 0 | |
| 1 | Submissions Specialist | 1 | 0 | |
| 0 | Technical Product Manager | 0 | 0 | |
| 0 | Training Specialist I | 0 | 0 | |
| 0 | Training Specialist IV | 0 | 0 | |
| 39 | 36.5 | 2.5 |
File details come from the government source that posted it. Updated .