o Serve as the site facing role for clinical operations at sites within the region.
o Expedites the pre-study and study initiation processes including conduct of Pre-Study Evaluation and Site Initiation Visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to train site personnel regarding the protocol and applicable regulatory requirements.
o Identifies, evaluates and recommends potential investigators/sites on an on-going basis within assigned region.
o Critically reviews and analyzes site activities through targeted risk based site contacts and on-site visits to monitor study sites protocol execution and compliance to applicable BMS SOPS, subject protection and ICH and/or FDA GCP Guidelines and other local regulations. This includes but is not limited to: Manage multiple protocols, across therapeutic areas but primarily oncology. This may require limited travel, based upon assigned site location and or/geographic territory. Significant travel outside of region is rare.
o Proactively communicates, and escalates with all internal and external stakeholders any significant issues identified at study sites while developing corresponding mitigation strategies and solutions, including the following activities: root cause analysis, corrective, and preventative action plans.
o Ensures timely entry and quality of data submitted from study sites.
o Supervises overall activities of site personnel over whom there is no direct authority and motivates and influences site personnel to meet study and timeline objectives.
o Ensures documented follow-up to all outstanding issues within monitoring management system ensuring appropriate issue escalation to line manager and project team members as necessary.
o Facilitates, as needed, internal regulatory compliance audits and Health Authority inspections for assigned sites.
o Prepares and submits monitoring and management reports in a timely, accurate, concise and objective manner.
o Initiates, develops and grows professional and collaborative relationships with Principal Investigators, all study personnel and necessary institution stakeholders.
Position qualifications/requirements:
o 2-5 years of clinical research or pharmaceutical developmental experience, of which at least 2 years must be clinical research monitoring. Oncology Experience preferred.
o At minimum a Bachelor of Arts or Science, or equivalent, in health related field from an accredited institution.
o Thorough knowledge of ICH/FDA guidelines and understanding of global Health Authority (e.g., EMA, MHRA) regulations impacting activities in the US.
o Thorough technical working knowledge of Electronic Data Capture, Electronic Medical Records and computer based systems.
o Understanding of industry trends (Risk Based Monitoring, Remote Monitoring, Remote Source Data Verification/Review, etc.)
o Ability to resolve a majority of complex study/site related issues independently using functional expertise while exercising excellent judgment and decision making skills.
o Exhibits a high level of flexibility and adaptability for changing priorities and processes.
o Employs strong fiscal management of departmental budget by independently managing travel and functional expenses.
o Identifies innovative solutions to accomplish objectives while maximizing utilization of budget, resources and time.
o Demonstrates project management skills when engaging with stakeholders to ensure efficient management of timelines, resources, encountered challenges and stakeholders.
Locations
Seattle, WA - US
