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 the initial study synopsis to final deliverables, including database hard-lock, final TLFs, and CSR.

• Manage the implementation, timely execution, and conduct of clinical studies, including budgets, milestones, timelines, scope, resources, and vendor selection.

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

• Identify and mitigate risks while prioritizing competing tasks and issues.

• Lead the process of vendor identification, qualification, and selection.

• Establish and oversee systems such as EDC, IWRS, central laboratories, ePRO, and eDiary services.

• Support endgame data and statistical analyses for trials.

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

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

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

• Monitor and report program and study progress to Senior Management utilizing dashboards and trackers.

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

• Tackle challenges and resolve problems creatively to enhance clinical trial execution.

• Execute miscellaneous duties as assigned.

⛳️ Requirements

• Bachelor’s degree with over 5 years of experience in pharmaceutical or biotech-related clinical research, oncology, or research, with at least 1 year as a 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 selecting vendors.

• Exceptional interpersonal and communication skills, showcasing leadership qualities.

• Subject matter expertise in US and Global Regulations and Guidance, including SOPs, ICH-GCP, FDA-CFR, and ethical standards.

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

• Capability to remain stationary, standing or sitting, for extended periods.

• Ability to navigate within an office environment and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or consistently.

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

• Proficiency in performing repetitive motions involving the wrists, hands, and/or fingers.

• Competence in communicating with others to exchange information.

• Clear and conceptual thinking ability; excellent judgment, troubleshooting skills, problem-solving abilities, analysis, and discretion.

• Capability to manage work-related stress, multiple priorities, and deadlines.

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

🏝️ Benefits

• Equal-opportunity employer.

• Reasonable accommodations available upon request.

• Remote work environment.