Clinical Project Manager

Advanced Recruiting Partners; United States; Presencial; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

Advanced Recruiting Partners seeks a Clinical Project Manager (CPM) with a strong background in respiratory clinical research to oversee trials from start-up through closeout. You will coordinate sponsors, CROs, investigators, and internal teams to deliver study milestones on time and within budget.

The role requires ICH-GCP and FDA regulation knowledge, hands-on management of timelines, budgets, and vendor relationships, plus mentorship for junior staff.

Formación

• Bachelor's degree in Life Sciences, Nursing, Public Health, or related field.
• 3–5 years of clinical project management experience.
• Experience managing respiratory clinical trials (asthma, COPD, etc.).
• Strong knowledge of ICH-GCP, FDA regulations, and clinical research processes.
• Experience with EDC, CTMS, eTMF, and other trial systems.

Responsabilidades

• Serve as the primary liaison between sponsors, CROs, sites, and internal teams.
• Develop and maintain project timelines, study plans, and milestones.
• Monitor progress and mitigate project risks.
• Manage study budgets, timelines, and resources.
• Coordinate site activation, enrollment, monitoring, and database lock.
• Ensure compliance with ICH-GCP, FDA regulations, and SOPs.
• Oversee vendor relationships (labs, imaging, etc.).
• Facilitate sponsor meetings and status updates.
• Review study metrics and prepare reports for sponsors/leadership.
• Support regulatory submissions and study documentation as needed.
• Mentor and guide CRAs and project team members.

Conocimientos

Clinical trial management

Sponsor relationship management

Budget and timeline oversight

Regulatory compliance

Team leadership

Microsoft Office proficiency

Excellent communication

Educación

Bachelor's degree in Life Sciences, Nursing, Public Health, or related field

Herramientas

EDC

CTMS

eTMF

Descripción del empleo

Job Title: Clinical Project Manager (CPM) - Respiratory Clinical Research

Position Summary

We are seeking an experienced Clinical Project Manager (CPM) with a strong background in respiratory clinical research to oversee the planning, execution, and management of clinical trials. The ideal candidate will have experience managing respiratory studies, collaborating with cross-functional teams, ensuring regulatory compliance, and driving study milestones from start-up through closeout.

This individual will serve as the primary point of contact for sponsors, investigators, and study teams while ensuring projects are delivered on time, within budget, and in accordance with GCP, FDA regulations, and company SOPs.

Key Responsibilities

• Serve as the primary liaison between sponsors, CROs, investigative sites, and internal teams.
• Develop and maintain project timelines, study plans, and milestone tracking.
• Monitor study progress and proactively identify and mitigate project risks.
• Manage study budgets, timelines, and resource allocation.
• Coordinate site activation, patient enrollment, monitoring activities, and database lock.
• Ensure compliance with ICH-GCP guidelines, FDA regulations, protocol requirements, and company SOPs.
• Oversee vendor relationships, including central laboratories, imaging vendors, and specialty service providers.
• Facilitate sponsor meetings, project status updates, and cross-functional team meetings.
• Review study metrics and prepare project reports for sponsors and leadership.
• Support regulatory submissions and study documentation as needed.
• Mentor and provide guidance to Clinical Research Coordinators, Clinical Research Associates, and project team members.

Required Qualifications

• Bachelor's degree in Life Sciences, Nursing, Public Health, or a related field.
• Minimum of 3-5 years of clinical project management experience.
• Previous experience managing respiratory clinical trials (e.g., asthma, COPD, pulmonary fibrosis, cystic fibrosis, or other respiratory indications).
• Strong knowledge of ICH-GCP, FDA regulations, and clinical research processes.
• Experience working with EDC, CTMS, eTMF, and other clinical trial management systems.
• Excellent organizational, communication, and leadership skills.
• Ability to manage multiple studies simultaneously in a fast-paced environment.
• Strong problem-solving and decision-making abilities.

Preferred Qualifications

• Project Management Professional (PMP) certification or equivalent.
• Experience working with CROs and pharmaceutical or biotechnology sponsors.
• Familiarity with pulmonary function testing (PFTs), spirometry, respiratory devices, and respiratory endpoints.
• Experience managing multicenter clinical trials.
• Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Associate (CCRA) certification preferred.

Skills

• Clinical trial management
• Sponsor relationship management
• Budget and timeline oversight
• Regulatory compliance
• Team leadership
• Strong Microsoft Office and clinical software proficiency
• Excellent written and verbal communication skills