Senior Clinical Research Manager (In-House), Oncology

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

The In-house Sr. Clinical Research Manager, will oversee the day-to-day functions of assigned Site Monitors (SM) to ensure the monitoring team is meeting established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

The In-house Sr. Clinical Research Manager works collaboratively with internal and external team members and supports project team activities to ensure all study deliverables are completed on time and within budget. The In-house Sr. Clinical Research Manager will oversee clinical site management performed by the Lead Clinical Research Associate (CRA) and site monitors.

Key Responsibilities:

·       Supports the Director of Clinical Operations in management of Site Monitoring Team relating to regular timesheet and expense approvals.

·       Assists the Director of Clinical Operations in periodic and annual budget forecasting for site monitoring across programs.

·       Supports implementation of global initiatives to ensure monitoring training and conduct are consistent.

·       Participates in and may facilitate cross-functional study teams, liaise with other functional areas to coordinate clinical study monitoring-related activities.

·       Coordinates with study project leads on clinical study timelines to meet critical milestones; escalate monitoring-related issues that may jeopardize timelines and deliverables.

·       Provides monitoring oversight by reviewing monitoring schedules, metrics and reports.

·       May review monitoring visit reports; liaise with monitors to understand any trends on quality issues or other site issues to develop solutions. Provides regular updates of study monitoring progress; proactively identifies and resolves issues that arise during study conduct; manages escalation of monitoring-related issues.

·       Participates in development and review of study plans; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study documents.

·       Implements appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.

·       Provides oversight of monitoring-related site level TMF document collection and filing, as well as collaboration with project-specific TMF Specialist to ensure inspection readiness of the TMF.

·       Contributes to study feasibility assessments and selection of countries and sites for study conduct.

·       Works with Lead CRA to develop monitoring training and may conduct internal/external training sessions including investigator meetings

·       All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOP's.

·       Mentors’ junior members of the team.

·       Performs other duties as assigned.

Professional Experience/Qualifications:

·       Minimum of 6 years CRA experience in the pharmaceutical/biotech industry.

·       Bachelors Degree Required.

·       Must have strong knowledge of ICH/GCP guidelines.

·       Comprehensive understanding of the drug development process.

·       Prior oncology drug development experience preferred.

·       Adept at working with a cross-functional project team.

·       Strong interpersonal, communication and leadership skills.

·       Proficient with MS office suite.

·       High level of organizational skills.

·       Demonstrated ability to work independently in a matrix environment.

·       Demonstrated ability to prioritize and manage multiple tasks simultaneously.

·       Demonstrated ability to influence through collaboratio