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Detailed Description

The Clinical Project Director has the responsibility of the oversight, planning, initiation, and execution of Clinical Operations programs/ studies as assigned.  

• Provides leadership, direction and management to clinical operations and cross functional teams for assigned studies
• Oversees the quality related to activities to ensure client deliverables are met
• Serves as primary point for clinical project management and monitoring strategy and overall project alignment both internally and externally for assigned studies
• May liaise with other departments or business units to optimize resources as well as to harmonize clinical operations practices, processes, and tools
• Contribute operational initiatives and continuous improvement
• Uses, metrics, dashboards, and reports to analyze compliance and quality of services to ensure clinical operations and cross functional delivery, manages escalated project and site related matters to drive follow-up action plans and improve departmental procedures
• Participates and leads in the financial review of project status and drives financial performance, particularly as related to clinical operations
• Guides internal teams and sponsors through and documents the key decisions needed to implement a high-quality project delivery. This includes close interaction with project management, data management, quality assurance, biostatistics, medical monitoring, and any other cross functional teams internally and externally as aligned to the assigned study
• Oversees the identification of critical data and process, the assessment of risks to protocol execution and clinical delivery, risk and issue tracking and risk and issue mitigation strategies
• Provides operational oversight and guidance to support prioritization of activities, reviews and monitors the work performed, metrics compliance, and development of contingency plans, among others
• Functions as point of escalation for internal and external teams as per the study assignment. This includes, but is not limited to, cross functional teams, client, and vendors
• Oversees progress of teams supporting clinical projects
• As assigned, may participate in the work streams to support the development and implementation of new initiatives and strategic direction of the Clinical Operations department and cross-functionally
• Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH GCP
• Ensures individual and team tasks are completed according to country/region specific and government regulations and per Sponsor/Customer expectations and contract
• Develops and supports customer relationships, manage customer expectations, and escalates more serious risks and issues as required
• Identifies needs and may make recommendations for process improvement and efficiencies
• As assigned, may provide support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required. This may include client presentations and contributions to the proposal development
• Reviews workload, utilization, productivity, and quality for staff on the assigned study
• As required, may participate in audits of clinical trial delivery and the audit follow up

REQUIREMENTS

• Ability to understand, explain and communicate project concepts and put into detailed plans
• Requires above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, encourage, and motivate
• Excellent verbal, written, presentation and communication skills are desired
• Knowledge of FDA and/or applicable regional regulations, ICH GCP Guidelines, and any other applicable regulatory requirements that govern conduct of clinical trials
• Experience in working in eTMF, CTMS, EDC, DCT and overall systems that support conduct of clinical trials
• Experience managing and/or mentoring junior staff
• Bachelor’s degree or advanced degree (e.g., Master, PharmD, PhD) preferred. Candidates with equivalent combination of education, training, and experience will be considered.
• 7 years of industry experience preferred with direct clinical project management experience or equivalent.