OverviewThe Clinical Business Operations Lead plays a critical role in supporting program-level enrollment planning and capacity forecasting across the clinical portfolio. This position leads the development and management of clinical operations and vendor KPIs, ensuring transparency and accountability through routine tracking and dashboard reporting to senior leadership.The ideal candidate brings strong analytical and operational skills, with the ability to oversee high-level program metrics while remaining agile to support study-level needs, including document development and eTMF support, as resourcing requires. This role is pivotal ss-functional coordination, and informed decision-making throughout clinical development.Essential Functions and ResponsibilitiesEffectively tracks and communicate clinical portfolio/program/study progress to Senior Management with ability to create and update detailed dashboards and trackersCritically assess data to detect trends and outliers to efficiently direct resources and attention to correct problems earlyAssist with the development and tracking of key performance indicators internally for clinical operations and vendor performanceSupport program level meetings and governance forums including meeting set up, meeting minutes, and action item follow upCreate action-oriented solutions for clinical trial scenario planning including but not limited to early budget planning templates, predictive enrollment forecasting, etcWhen needed contributor to the preparation and management of clinical study documents or eTMF supportAssist with inspection or audit readiness activitiesServe as clinical representative at hypercare and S&OPServe as clinical representative on the IovanceClinical PlatformMust adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.Perform miscellaneous duties as assignedTravelAvailable to travel as neededPreferred Education, Skills, and KnowledgeBachelor’s degree with 4+ years of pharmaceutical or biotech-related/clinical research, oncology or research experience or Master’s degree with 3+ years of pharmaceutical or biotech-related/clinical research, oncology or research experienceDemonstrated experience tiating and managing phase 1-4 clinical trialsDemonstrated experience clinical trial ad hoc vendor selectionPossessing excellent interpersonal and communication skills, with demonstrated leadership attributesPositioned as a subject matter expert in application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards)Work EnvironmentThis job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.Physical Demands and Activities RequiredMust 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 to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.Must be able to communicate with others to exchange information.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 deadlinesPay Transparency$145,000—$155,000 USD
about 1 month ago