Clinical Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the overall operational execution of clinical studies across one or more clinical programs, from the initial study synopsis to the final project deliverables (i.e., database hard-lock, final TLFs, CSR, etc.).

• Oversee the implementation, timely execution, and conduct of clinical studies, including the development of budget items, milestones, and timelines, as well as resource management (including vendor selection). This ensures overall quality, safety, and compliance throughout the duration of the clinical studies and program.

• Supervise cross-functional study team members to guarantee the initiation and execution of the clinical program within the approved budget and timelines.

• Manage risk and mitigation strategies, prioritizing competing tasks and issues to ensure that program/study objectives are successfully met.

• Take a leading role in vendor identification, qualification, and selection, as well as systems setup and management, including EDC, IWRS, Central Laboratories, and specialty services (ePRO, eDiary, etc.).

• Have a comprehensive understanding of how to support and deliver the trial endgame, particularly in data and statistical analyses.

• Critically evaluate data to identify trends and outliers, directing resources and attention to rectify problems promptly.

• Possess the ability to critically review and supervise multi-functional vendor groups, including clinical operations, data management, and biometrics.

• Ensure data integrity through regular data reviews, queries, resolutions, and consistency checks both internally and for independent DMC/DSC.

• Effectively track and communicate program/study progress to Senior Management, with the capability to create and update detailed dashboards and trackers.

• Stay informed about the competitive landscape, evolving regulations, and guidance, assessing their impact on clinical projects and making necessary modifications.

• Approach challenges and problem resolution creatively to optimize the conduct of clinical trials.

• Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

• Perform miscellaneous duties as assigned.

⛳️ Requirements

• Bachelor’s degree with 5+ years of experience in pharmaceutical or biotech-related clinical research, oncology, or research experience, including at least 1 year as CTM.

• Proven experience in the core and technical aspects of designing, initiating, and managing phase 1-4 clinical trials.

• Demonstrated experience in managing CROs and in vendor selection.

• Excellent interpersonal and communication skills, with demonstrated leadership qualities.

• Recognized as a subject matter expert in the application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards).

• Broad experience in data collection, monitoring, cleaning, and analysis throughout clinical development (Phase 1-4).

🏝️ Benefits

• Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.