Senior Project Manager - Respiratory

Job Description

ClinChoice is seeking a Senior Clinical Project Manager to join their US team in Horsham, Pennsylvania. This is a hybrid role, with remote work considered for those outside of PA. The Senior Clinical Project Manager will lead cross-functional teams and manage complex projects, ensuring quality in accordance with contractual obligations, SOPs, ICH-GCP guidelines, and other regulations. Previous experience working with a CRO and managing respiratory trials is required, with oncology experience preferred.Responsibilities:

• Manage and coordinate assigned clinical projects.
• Manage project-specific services (central lab exams, drug shipments, etc.).
• Manage the development of clinical projects, interacting with sponsors and investigators.
• Collect and manage study data documentation.
• Assure project timelines and manage the budget.
• Monitor workload and performance of the project team.
• Coordinate CRAs and Clinical Monitors.
• Collaborate with Biometrics team and other project team members.
• Assist in preparing protocols, Case Report Forms, and Clinical Study Reports.
• Deliver project-specific trainings.
• Organize and participate in meetings.
• Provide project updates.
• Perform co-monitoring visits.
• Act as a tutor for Project Coordinators and Project Manager I.
• Maintain relationships with the Sponsor.
• Prepare SOPs.

Requirements:

• Bachelor's Degree in a scientific, medical, or paramedical discipline.
• 8+ years of clinical research experience in Project Management.
• Experience managing respiratory studies.
• CRO experience.
• Knowledge of clinical trial operations, GCP/ICH Guidelines, and regulatory requirements.
• Fluent in English.
• Proficiency in Microsoft Office.

The role offers:

• Opportunity to work with a global full-service CRO.
• Professional development and work-life balance.
• Collaborative "one-team" culture.
• Chance to improve peoples' lives.