Contractor – Clinical Trial Manager

This is a fully remote position, open to applicants in New York.

📋 Description

• Oversee and direct the daily operations of assigned clinical trials while ensuring adherence to GCP/ICH guidelines and regulatory standards.

• Engage in or lead cross-functional study teams, including collaboration with vendors.

• Manage the coordination of clinical study activities across different functional areas.

• Supervise lab sampling procedures and manage relationships with lab vendors.

• Create informed consent forms, training materials, and study tools.

• Contribute to the design of protocols, informed consent forms, case report forms, monitoring conventions, edit checks, and vendor specifications.

• Review, authorize, and finalize critical study documents.

• Monitor the performance of CROs and third-party vendors, addressing any issues that arise.

• Clarify and elucidate the requirements of study protocols.

• Identify potential risks and formulate strategies for their mitigation.

• Oversee study timelines and deliver progress updates to management.

• Track key study metrics such as patient visits, data entry, monitoring, and data cleaning.

• Review invoices in relation to statements of work.

• Assist in the development and implementation of standard operating procedures (SOPs).

⛳️ Requirements

• Bachelor’s Degree in a life sciences or healthcare-related field.

• Minimum of 5 years of clinical trial management experience within the pharmaceutical industry or a CRO, with increasing responsibilities in operations.

• Comprehensive understanding of clinical trials from initiation to conclusion, including familiarity with Inspection Readiness.

• Experience in oncology trials is preferred.

• Capability to lead productive meetings and ensure effective cross-functional communication regarding key study decisions and milestones.

• Solid knowledge of GCPs, FDA regulations, and ICH guidelines.

• Experience in managing external service providers.

• Familiarity with international clinical trials, particularly those conducted in the EU, CA, and Australia.

• Strong understanding of data management, biostatistics, regulatory affairs, and pharmacovigilance.

• Excellent verbal and written communication skills.

• Ability to prioritize tasks and work autonomously.

• Willingness to travel approximately 5–10%, both domestically and internationally.

🏝️ Benefits

• Comprehensive healthcare coverage.

• Opportunities for professional development and growth.

• Flexible working hours and a supportive work environment.

• Competitive salary and performance-based bonuses.