Senior Project Manager - Rare Disease

Location: United States. Remote work is supported; employees located within a reasonably short commute of an office may work on a hybrid basis as agreed with their manager.

Company

hirify.global provides consulting and operational solutions across the pharmaceutical, biotechnology, medical device, regulatory, clinical research, quality, compliance, pharmacovigilance, medical information, and R&D technology lifecycle.

What you will do

• Plan and manage assigned rare disease clinical studies from start-up through closeout, including timelines, budgets, deliverables, and resourcing.
• Identify project risks, delays, and issues; develop contingency plans and coordinate risk mitigation across functional areas.
• Serve as the primary communication point for internal and external clinical project teams, clients, sponsors, investigators, and cross-functional stakeholders.
• Develop and maintain study project plans, study-specific tools, templates, metrics, training materials, and operational documentation.
• Manage vendors, study drug and site supplies, investigator meetings, contracting activities, shipments, tracking, and resupply.
• Oversee study TMF maintenance and quality review, regulatory and SOP compliance, recruitment and retention initiatives, and study reporting.

Requirements

• Experience managing clinical studies from initiation through closeout.
• Ability to manage project budgets, timelines, metrics, change orders, margins, risks, and deliverables.
• Knowledge of FDA and ex-US regulations, ICH-GCP requirements, local regulatory requirements, and corporate SOPs.
• Experience preparing or contributing to protocols, ICFs, CRFs, monitoring plans, safety plans, clinical data review plans, and clinical study reports.
• Ability to coordinate cross-functional teams, vendors, investigator meetings, training, and client communications.
• Must be based in the United States.

Culture & Benefits

• Remote working is supported.
• Hybrid work may be available for employees located near an office, subject to agreement with the manager.
• Inclusive workplace focused on diversity, equity, and inclusion.
• Work environment encourages collaboration, innovation, entrepreneurship, and authenticity.
• Applications are personally reviewed by the recruitment team, with an outcome provided to every applicant.