Study Manager – Respiratory

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversees interdisciplinary clinical research studies as a project manager, ensuring adherence to GCP, relevant SOPs, and regulatory standards.

• Serves as the main point of contact between the Company and the Customer, ensuring the timely initiation, execution, and conclusion of studies in accordance with the contractual agreement.

• Leads the project team to guarantee quality, adherence to timelines, and effective budget management.

• Responsible for the financial performance of each assigned project.

• Coordinates the activities and deliverables of all study conduct partners, proactively identifying and addressing issues.

• Ensures compliance with GCP, relevant SOPs, and regulatory requirements during study execution.

• Accountable for all project deliverables for each assigned project.

• Responsible for the quality and completeness of the Trial Master File (TMF) for assigned projects.

• Manages the maintenance of study information across various databases and systems.

• Oversees study management components to ensure inspection readiness for all aspects of study conduct.

• Provides oversight for the creation and execution of project plans.

• Plans, coordinates, and presents at both internal and external meetings.

• Prepares project management reports for clients and management.

• Develops contingency plans and risk mitigation strategies to ensure the successful achievement of study objectives.

• Fosters strong relationships with existing clients to cultivate new and/or additional business opportunities.

• May take part in bid defense meetings while being presented as a potential project manager.

• May be tasked with line management responsibilities for other project management team members and clinical monitoring personnel.

⛳️ Requirements

• A Bachelor's Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or a related combination of education and experience.

• Experience in a Clinical Research Organization (CRO) and relevant therapeutic areas is preferred.

• Strong understanding of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.

• Excellent organizational skills.

• Strong capability to manage time efficiently and work independently.

• Direct expertise in therapeutic areas.

• Willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal skills, both written and verbal.

• Ability to travel as needed (approximately 25%).

🏝️ Benefits

• Health benefits including Medical, Dental, and Vision coverage.

• Company-matched 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on both company and individual performance.

• Flexible paid time off (PTO) and sick leave.