Attachment E - Labor Categories Minimum Qualifications.docx

DOCX document 24 KB Posted

Attached to
Post-Market Bioequivalence of Generic Drug Products
Solicitation number
Amendment75F40123R00023
Issued by

About this file

Written by GovTribe AI ·

This document provides minimum qualifications for labor categories on a federal contract. It defines two key roles: Project Manager and Contract Manager. The Project Manager would work as a liaison between the FDA and clinical trial sites, coordinating required activities, developing and maintaining project plans and timelines, communicating regularly with the FDA, overseeing risk management, and managing Phase I clinical trials. Minimum qualifications include a bachelor's degree in a life science field, five years of clinical trial management experience including IND studies, and preferred certifications. The Contract Manager would oversee contract administration throughout the project period by developing and managing the contract, budget, and timeline. This role requires drafting modification requests, ensuring deliverables meet acceptance criteria, submitting invoices, and ensuring compliance. Minimum qualifications consist of a bachelor's degree in business, law, accounting or similar, five years of contract and budget management experience for clinical trials, and preferred experience with federal contracts.

View the file

Other files

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

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file
Try for free Login

Text version

The file's text, extracted by GovTribe without its formatting.

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 .