Clinical Trial Manager Jobs

Overview

The Clinical Trial Manager has operations experience within the biotech/biopharma arena. This individual has a high level of core competencies and technical skills to be applied within the management of clinical programs leading to registrational submissions of Biologic License Applications (BLAs).

The Clinical Trial Manager position is an opportunity for an individual to join a cross-functional clinical team having high-visible and dynamic input in a therapeutic indication of unmet medical need and orphan disease status.

Essential Functions And Responsibilities

• Manage the implementation, on-time execution and conduct of clinical studies; including the development of budget items, milestones and timelines, in addition to scope and management of resources (including vendor selection). All leading to overall quality, safety, and compliance throughout the duration of the clinical studies and program.
• Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished.
• Oversight of cross-functional study team members to ensure initiation and execution of the clinical program within approved budget and timelines
• Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials
• Perform miscellaneous duties as assigned.
• Awareness of competitive landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary
• Ability to critically review and supervise a multifunctional vendor groups including clinical operations, data management and biometrics
• Understanding of how to support and deliver the trial endgame, which is the data and statistical analyses
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Lead role in vendor identification/qualification/selection, systems set-up/management including EDC, IWRS, Central Laboratories, specialty services (ePRO, eDiary, etc.)
• Support the overall operational execution of clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (ie, database hard-lock, final TLFs, CSR, etc.)
• Critically assess data to detect trends and outliers to efficiently direct resources and attention to correct problems early
• Effectively tracks and communicate program/study progress to Senior Management with ability to create and update detailed dashboards and trackers
• Ensure data integrity through routine data reviews, query and resolution, consistency checks both internally and for independent DMC/DSCO

Required Education, Skills, And Knowledge

• Demonstrated experience in core and technical aspects of designing, initiating and managing phase 1-4 clinical trials
• Bachelor’s degree with 5+ years of pharmaceutical or biotech-related/clinical research, oncology or research experience
• Demonstrated experience in management of CROs, in vendor selection
• Possessing excellent interpersonal and communication skills, with demonstrated leadership attributes
• Positioned as a subject matter expert in application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards)
• Broad scope experience in data collection, monitoring, cleaning and analysis throughout clinical development (Phase 1-4)

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Ability to lift 20 lbs.
• Ability to stand/sit/walk for long periods of time.
• Must meet requirements for and be able to wear a half-face respirator.
• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.

Mental

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline.

Work Environment

• This position will work in both an office and a manufacturing setting.
• Must be able to work in cleanroom lab setting with biohazards / various chemicals
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Potential exposure to variable noise levels, equipment hazards, strong odors, latex, bleach, and other detergents/sanitizers.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact [email protected]

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