Clinical Trial Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $145k - $165k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Iovance Biotherapeutics, Inc. is pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and attack diverse cancer cells in each patient. The company focuses on T-cell-based immunotherapy, specifically Tumor Infiltrating Lymphocyte (TIL) therapy, which involves reinvigorating a patient’s TILs to fight cancer. Iovance's TIL therapy is being investigated in clinical trials across multiple advanced solid tumor cancers. Additionally, the company is advancing genetically modified TIL therapies and exploring potential applications of PBL (peripheral blood lymphocyte) therapy for blood cancers. As a leader in cell therapy, Iovance owns a state-of-the-art Cell Therapy Center in Philadelphia for manufacturing their therapies using proprietary GMP. The company is at the forefront of developing personalized and patient-specific cancer treatments.

📋 Description

• Support operational execution of clinical studies across one or more clinical programs from study synopsis through final deliverables, including database hard-lock, final TLFs, and CSR • Manage implementation, timely execution, and conduct of clinical studies, including budgets, milestones, timelines, scope, resources, and vendor selection • Oversee cross-functional study team members to ensure execution within approved budgets and timelines • Manage and mitigate risks, prioritize competing tasks and issues, and achieve program/study objectives • Lead vendor identification, qualification, and selection; manage systems including EDC, IWRS, central laboratories, ePRO, and eDiary • Support and deliver trial endgame data and statistical analyses • Assess data to detect trends and outliers and direct resources to resolve problems early • 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 • Track and communicate program/study progress to senior management using dashboards and trackers • Assess competitive landscape, changing regulations, and guidance and modify clinical projects as necessary • Develop creative approaches to challenges and problem resolution to optimize clinical trial conduct • Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics • Perform miscellaneous duties as assigned

🎯 Requirements

• Bachelor’s degree with 5+ years of pharmaceutical or biotech-related/clinical research, oncology or research experience and at least 1 year as CTM • Demonstrated experience in core and technical aspects of designing, initiating and managing phase 1-4 clinical trials • Demonstrated experience in management of CROs, in vendor selection • Excellent interpersonal and communication skills, with demonstrated leadership attributes • Subject matter expertise in 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) • Must be able to remain in a stationary position standing or sitting for prolonged periods of time • Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects • Must have visual acuity for preparing and analyzing data and figures, viewing a computer screen, and extensive reading • Requires repetitive motion and substantial movements of the wrist, hands, and/or fingers • Must be able to communicate with others to exchange information • Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress, multiple priorities, and deadlines