Attachment E - Labor Categories Minimum Qualifications.docx

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Post-Market Bioequivalence of Generic Drug Product
Solicitation number
75F40124R00023
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This document provides minimum qualifications for labor categories for a federal contract opportunity. The labor categories include Project Manager, Contract Manager, and descriptions of required education, certifications, licensure, and experience for each. The Project Manager would work as a liaison between the FDA and clinical trial teams, coordinating required activities and supporting communication. The Contract Manager would oversee contract administration and develop and manage the contract, timeline, and budget. Both require at least a Bachelor's degree and five years of relevant managing experience. The related federal contract opportunity is for post-market bioequivalence studies of generic drug products from the Department of Health and Human Services FDA. The solicitation number is 75F40124R00023.

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QA response.xlsx XLSX spreadsheet
75F40124R00023.pdf PDF
Attachment F - Sample Task Order Statement of Work.docx DOCX document
Attachment B - FAR 52.212-5-Contract-Terms-and-Conditions (SEP 2023) (Updated).docx DOCX document
RFP.pdf PDF
Attachment A - Pricing for Sample Task Order.xlsx XLSX spreadsheet
Attachment H - Past Performance Questionnaire.doc DOC document
Attachment D - HHS Class Deviation 2020-02 - Accelerated Payments.pdf PDF
Attachment G - Labor Categories Minimum Qualifications Sample Task Order.docx DOCX document
Attachment C - FAR Deviation 18-01 (Whistleblower Protection-Commercial).pdf PDF

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Attachment No: E Labor Categories & Minimum Qualifications for Contract

Labor Categories

Name
Description
Project Manager
· Works as a liaison between FDA and the site personnel/project teams to coordinate all required activities.

· Supports the planning, coordination, and execution of all clinical trials and its related activities.

· Develops, adjusts, and maintains the project plan including the timeline.

· Supports clear communication between FDA and the site personnel/project teams.

· Proposes and implements methods to track and complete multiple projects effectively and efficiently.

· Schedules and meets with FDA monthly or as needed, and communicate in a timely manner, to ensure work meets/exceeds the project objectives.

· Takes and finalizes meeting minutes.

· Oversees risk management activities involving timeline management, quality standards, and risk mitigation.

· Reads, writes, and speaks fluent English;

· Excellent verbal and written communication skills.

· High level of organization, time management and problem solving skills

· Experience managing Phase I type clinical trials.

· Bioequivalence/bioavailability study management experience is preferred.

· Education: Bachelor’s Degree in life science, science, health care, or related field.

· Certifications: PMP preferred, but not required. CCRP (SoCRA) or CCRA (ACRP) certifications preferred.

· Licensure: Not required

· Experience: Minimum five years of managing experience of clinical trials including IND studies required.

Contract Manager
· Oversees the contract administration throughout the project periods.

· Develops and manages the contract.

· Develops and manages overall project timeline with project manager.

· Develops and manages the budget.

· Drafts and submits the modification request(s) as needed in a timely manner.

· Ensures deliverables meet the acceptance criteria.

· Submits the invoices per deliverable table in consultation with project manager.

· Ensures compliance with contractual requirements.

· Reads, writes, and speaks fluent English;

· Excellent verbal and written communication skills.

· Experience with Experience with the federal contract is preferred.

· Education: Bachelor’s Degree in business, law, accounting or related field.

· Certifications: Not required

· Licensure: Not required

· Experience: Minimum five years of managing experience of contract and budget for clinical trials required.

File details come from the government source that posted it. Updated .