Attachment E - Labor Categories Minimum Qualifications.docx

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Post-Market Bioequivalence (BE) Studies
Solicitation number
FDAFO121683-Amendment
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Attachment E details minimum qualifications for two critical labor categories in a post-market bioequivalence study contract for the FDA: Project Manager and Contract Manager. The Project Manager role requires a bachelor's degree in life sciences, minimum five years of clinical trial management experience, preferably in Phase I and bioequivalence studies, with desired certifications like PMP, CCRP, or CCRA. Key responsibilities include coordinating clinical trial activities, managing project timelines, facilitating communication between FDA and site personnel, and overseeing risk management.

The Contract Manager position requires a bachelor's degree in business, law, or accounting, with minimum five years of contract and budget management experience for clinical trials. This role focuses on contract administration, including developing and managing contracts, project timelines, budgets, modification requests, and ensuring deliverable compliance. Both positions require fluent English, excellent communication skills, and a professional approach to managing complex clinical research projects for the Department of Health and Human Services Food and Drug Administration.

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Attachment 1-Price Worksheet.docx DOCX document
Attachment H - Past Performance Questionnaire.doc DOC document
Attachment F - Sample Task Order Statement of Work.docx DOCX document
Questions.docx DOCX document
Attachment G - Labor Categories Minimum Qualifications Sample Task Order.docx DOCX document

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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 .