Senior Clinical Trial Manager

3 days ago

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Iovance Biotherapeutics, Inc.

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Immuno Oncology • Autologous Cell Therapy • Tumor Infiltrating Lymphocytes (TIL) • Novel Cancer Immunotherapies • cell therapy

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• 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.) • 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). • Oversight of cross-functional study team members to ensure initiation and execution of the clinical program within approved budget and timelines. • Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished. • Lead role in vendor identification/qualification/selection, systems set-up/management including EDC, IWRS, Central Laboratories, specialty services (ePRO, eDiary, etc.). • Understanding of how to support and deliver the trial endgame, which is the data and statistical analyses. • Critically assess data to detect trends and outliers to efficiently direct resources and attention to correct problems early. • Ability to critically review and supervise a multifunctional vendor groups including clinical operations, data management and biometrics. • Ensure data integrity through routine data reviews, query and resolution, consistency checks both internally and for independent DMC/DSC. • Effectively tracks and communicate program/study progress to Senior Management with ability to create and update detailed dashboards and trackers. • Awareness of competitive landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary. • Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials.

Requirements

• Bachelor’s degree with 6+ years of pharmaceutical or biotech-related/clinical research, oncology, or research experience. • 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. • 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).