Associate Director of Clinical Monitoring (440630)
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Overview:This position is responsible for the oversight of clinical monitoring activities, including managing activities of Clinical Research Associates (CRAs) employed by Client or contracted through a Clinical Research Organization (CRO) or other CRA resourcing entity. The AD, Clinical Monitoring is responsible for development, implementation, and oversight of novel monitoring approaches, such as risk-based monitoring, remote data review, and key risk indicator review/action.Essential Functions:Ensure clinical monitoring activities are conducted in alignment with Good Clinical Practices (GCP) and relevant national and international guidelines/requirements.Oversee and participate in clinical monitoring vendor selection process.Contribute to clinical monitoring contract negotiation and ongoing budget management.Ensure CRAs meet Client experience and performance expectations.Oversee and participate in CRA training (GCP, therapeutic, and protocol-specific).Review study protocols to recommend monitoring approach, including monitoring visit frequency, acceptable level of source document verification, and key risk indicators.Develop, implement, and oversee risk-based monitoring (RBM) methodologies.Facilitate cross-functional risk assessment activities using risk assessment categorization tool (RACT), including protocol- and site-level risk assessments.Develop remote data review processes and assign action plans, as required.Ensure study-specific monitoring plan is in place for each study, in alignment with Client SOPs.Ensure monitoring visit reports (MVRs) and all relevant documents are generated, reviewed, and archived as outlined in the study-specific monitoring plan.Collaborate with Clinical Trial Management (CTM) group to ensure clinical sites and investigators are conducting studies in compliance with ICH/GCP guidelines and study protocol; ensure CTMs are reviewing MVRs to identify potential compliance trends.Perform or oversee co-monitoring visits to ensure CRA performance is in alignment with Client expectations and that monitoring is being conducted in alignment with ICH/GCP guidelines and study-specific monitoring plan.Participate in development and maintenance of clinical monitoring SOPs, tools, and document templates (e.g. monitoring plan and MVR templates).Mentor and train in-house CRAs.Manage day-to-day operations of the in-house clinical monitoring staff including recruitment of staff, evaluation and communication of employee performance on an on-going basis, participation in compensation process, and direction and prioritization of staff workloads.Participate in department and cross-functional process improvement initiatives.Act on constructive feedback from peers, supervisors, and colleagues to improve performance and provide feedback to direct reports and colleagues. Education/Experience Requirements:Bachelor's degree with greater than five years of monitoring experience with lead CRA and global experience preferred.Knowledge and skills (general and technical):Demonstrated proficiency in all aspects of clinical monitoring, including risk-based monitoring methodologies.Experience in oversight of contract resources and familiarity with the lifecycle of a clinical trial: from protocol development and feasibility through study close-out and reporting.Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists.Excellent written and oral communication skills in order to effectively communicate in English.Ability to communicate in medical and scientific terms with vendors, consultants, and peers in English.Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations in English.Ability to write reports, business correspondence and procedure manuals in English.Ability to effectively present information to and respond to questions from groups of managers, sites, etc. in English.Must have experience interfacing and managing multiple vendors and contracts.Ability to manage time, multi-task and prioritize in order to complete deliverables on schedule.Confidential Data/Compliance:All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Client are carried out with the \\"best\\" industry practices and the highest ethical standards.Mental/Physical Requirements:Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary.Requires a high level of initiative and independence.Excellent written and oral communication skills required.Requires ability to use a personal computer for extended periods of time.Up to 50% travel may be required.
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