Study Manager – Oncology

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, applicable SOPs, and regulatory standards.

• Serves as the primary point of contact between the Company and the Customer, facilitating timely study initiation, execution, and completion in line with contractual agreements.

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

• Responsible for the financial outcomes 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 throughout the study process.

• Holds accountability for all project deliverables associated with each assigned project.

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

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

• Responsible for the study management components related to inspection readiness for all facets of study conduct.

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

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

• Prepares project management reports for clients and internal stakeholders.

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

• Cultivates strong relationships with current clients to foster new and/or additional business opportunities.

• May take part in bid defense meetings as a prospective project manager.

⛳️ Requirements

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

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

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

• Excellent organizational skills.

• Proven ability to manage time effectively and work independently.

• Expertise in direct 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

• Company car or car allowance.

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

• Company-matched 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

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