Clinical Trial Manager

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

📋 Description

• Assist in the operational execution of clinical studies across one or multiple clinical programs, from study synopsis through to final deliverables, such as database hard-lock, final TLFs, and CSR.

• Oversee the implementation, timely execution, and conduct of clinical studies, managing aspects like budgets, milestones, timelines, scope, resources, and vendor selection.

• Supervise cross-functional study team members to ensure execution is within the approved budgets and timelines.

• Identify and mitigate risks, prioritize competing tasks and issues, and meet program/study objectives.

• Lead the identification, qualification, and selection of vendors; manage systems including EDC, IWRS, central laboratories, ePRO, and eDiary.

• Support and deliver trial endgame data and statistical analyses.

• Analyze data to identify trends and outliers, directing resources to address issues proactively.

• Review and supervise multifunctional vendor groups across clinical operations, data management, and biometrics.

• Ensure data integrity through routine reviews, query resolution, and consistency checks, including for independent DMC/DSC.

• Monitor and communicate program/study progress to senior management using dashboards and trackers.

• Evaluate the competitive landscape, changing regulations, and guidance, adjusting clinical projects as necessary.

• Develop innovative solutions to challenges and problem resolution to optimize the conduct of clinical trials.

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

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor's degree with over 5 years of experience in pharmaceutical or biotech-related/clinical research, oncology, or research, including at least 1 year as a Clinical Trial Manager (CTM).

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

• Documented experience in managing Contract Research Organizations (CROs) and in vendor selection.

• Outstanding interpersonal and communication skills, demonstrating leadership qualities.

• Expertise in US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards).

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

• Ability to remain stationary in a standing or sitting position for extended periods.

• Capability to navigate within an office environment and occasionally exert up to 10 pounds of force, or a negligible amount frequently or constantly to lift, carry, push, pull, or otherwise move objects.

• Visual acuity necessary for preparing and analyzing data and figures, viewing a computer screen, and extensive reading.

• Requires repetitive motion and significant movements of the wrist, hands, and/or fingers.

• Must be able to communicate effectively with others to share information.

• Possess clear and conceptual thinking abilities; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; capacity to manage work-related stress, multiple priorities, and deadlines.

🏝️ Benefits

• Competitive salary and performance bonuses.

• Comprehensive health insurance coverage.

• Opportunities for professional development and career advancement.

• Flexible work arrangements.

• A collaborative and inclusive work environment.