Study Manager – Cardiovascular

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

📋 Description

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

• Serves as the main point of contact between the Company and the Customer to guarantee timely study initiation, execution, and conclusion in alignment with the contractual agreement established with the Customer and the Company.

• Leads the project team to maintain quality, manage timelines, and control budgets effectively.

• Responsible for the financial outcomes of each project.

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

• Ensures that studies are executed in compliance with GCP, relevant SOPs, and regulatory guidelines.

• Accountable for all project deliverables for each assigned project.

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

• Responsible for the upkeep of study information across various databases and systems.

• Manages the study components related to inspection readiness for all facets of study execution.

• Supervises the development and implementation of project plans.

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

• Prepares project management reports for clients and management teams.

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

• Cultivates strong relationships with existing clients to foster new and/or additional business opportunities for the future.

⛳️ Requirements

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

• Preferred experience in clinical research organizations (CRO) and relevant therapeutic areas.

• Comprehensive knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.

• Strong organizational capabilities.

• Excellent time management skills and the ability to work independently.

• Direct expertise in the therapeutic area.

• 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.