Project Lead – Project Manager

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

📋 Description

• Act as the Project Lead and main contact for sponsors.

• Responsible for the overall success of the project, including quality, timeline, and budget.

• Set and relay customer expectations to the project team.

• Guide a cross-functional project team to achieve or surpass deliverables.

• Ensure adherence to organizational policies, standard operating procedures, and ICH-GCP guidelines.

• Oversee vendor management and financial responsibility at the trial level.

• Facilitate Risk Identification and Issue Resolution at the project level.

• Manage activities that fall outside the project scope and negotiate contracts.

⛳️ Requirements

• Bachelor’s degree in a scientific field (B.A. or B.Sc.).

• Over 6 years of experience in clinical operations management, overseeing clinical trials in accordance with quality, timelines, and budgetary expectations, ideally with a Sponsor organization and a CRO.

• Relevant scientific and clinical knowledge along with outstanding project management, risk assessment, contingency planning, and communication skills.

• In-depth understanding of clinical development pertaining to one or more trial phases (I, II, III), as well as cross-functional drug development processes.

• Proficient in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines, and regulatory requirements for clinical development.

• Capability to formulate and implement operational plans.

• Competent in technical and system applications, including effective use of software such as Microsoft Outlook, Word, Excel, and PowerPoint, as well as organizational systems.

• Ability to delegate tasks and effectively prioritize both personal and team workloads in a dynamic environment.

• Strong oral and written communication, along with presentation skills.

• Proactive, solution-oriented, and adaptable to shifting priorities and circumstances.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Professional development opportunities