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Clinical Study Management Lead

2 months ago

San Carlos, California, United States Iovance Biotherapeutics Inc Full time
Job Overview

Position Title: Clinical Trial Manager

Salary Range: $165,000 - $176,000

Position Summary:

The Clinical Trial Manager plays a pivotal role in overseeing clinical operations within the biotech and biopharmaceutical sectors. This role demands a robust set of core competencies and technical expertise essential for managing clinical programs that lead to regulatory submissions of Biologic License Applications (BLAs).

This position offers a unique opportunity to be part of a dynamic, cross-functional clinical team, contributing significantly to a therapeutic area characterized by unmet medical needs and orphan disease status.

Key Responsibilities:

  • Oversee the operational execution of clinical studies across multiple programs, from initial study design to final project deliverables (e.g., database lock, final tables, listings, and figures, Clinical Study Report).
  • Ensure timely execution and conduct of clinical studies, including budget development, milestone tracking, and resource management (including vendor selection), while maintaining quality, safety, and compliance throughout the clinical study lifecycle.
  • Provide oversight to cross-functional study team members to guarantee the initiation and execution of clinical programs within approved budgets and timelines.
  • Implement risk management strategies, prioritizing competing tasks and issues to achieve study objectives effectively.
  • Lead the identification, qualification, and selection of vendors, managing systems setup, including Electronic Data Capture (EDC), Interactive Web Response Systems (IWRS), and specialty services.
  • Support the trial endgame, focusing on data integrity and statistical analyses.
  • Critically evaluate data to identify trends and anomalies, directing resources to address issues proactively.
  • Supervise and review the performance of multifunctional vendor groups, including clinical operations, data management, and biostatistics.
  • Ensure data integrity through routine reviews, query resolution, and consistency checks, both internally and with independent Data Monitoring Committees/Data Safety Committees.
  • Effectively communicate program and study progress to senior management, creating and updating detailed dashboards and trackers.
  • Maintain awareness of the competitive landscape and evolving regulations, assessing their impact on clinical projects and making necessary adjustments.
  • Approach challenges creatively to optimize the conduct of clinical trials.
  • Adhere to Iovance Biotherapeutics' core values, policies, procedures, and ethical standards.
  • Perform additional duties as assigned.

Qualifications:

  • Bachelor's degree with a minimum of 5 years of experience in pharmaceutical or biotech-related clinical research, particularly in oncology.
  • Proven experience in the design, initiation, and management of Phase 1-4 clinical trials.
  • Demonstrated capability in managing Contract Research Organizations (CROs) and vendor selection processes.
  • Exceptional interpersonal and communication skills, showcasing leadership qualities.
  • Expertise in US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards).
  • Comprehensive experience in data collection, monitoring, cleaning, and analysis throughout the clinical development process.

Physical and Mental Demands:

  • Ability to remain stationary for extended periods and move within an office environment.
  • Capable of exerting up to 10 pounds of force occasionally or a negligible amount of force frequently.
  • Visual acuity for preparing and analyzing data, viewing computer screens, and extensive reading.
  • Ability to perform repetitive motions and communicate effectively with others.

Work Environment:

This position operates in a professional office environment, requiring the use of standard office equipment and technology.

The information provided in this document is intended to describe the general nature and level of work performed by individuals in this role. It is not intended to be an exhaustive list of all responsibilities, duties, or local variations. Management retains the discretion to modify the duties of the position as necessary.

Iovance is dedicated to fostering a diverse and inclusive workplace. As an equal opportunity employer, we consider all applicants without regard to race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, gender identity, or any other characteristic protected by law.