Manager Clinical Monitoring (440632)
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POST DATE 9/12/2016
END DATE 10/9/2016
Fort Lee, NJ
JOB DESCRIPTIONJob Description:
Overview:The Manager, Clinical Monitoring (MCM) is responsible for management and oversight of activities performed by Clinical Research Associates (CRAs) employed by Client or contracted through a Contract Research Organization (CRO) or CRA resourcing entity, including site management and prestudy site evaluations, site initiations, interim monitoring and site close out activities. The MCM also conducts monitoring/CRA activities, as needed. The MCM will contribute to development, implementation, and oversight of novel monitoring approaches, such as risk-based monitoring, remote data review, and key risk indicator review/action. Essential Functions:Serve as the primary point of contact for assigned investigational sites.Perform routine site visits including pre-study, initiation, interim, and closeout visits in accordance with contracted scope of work and good clinical practice.Establish regular lines of communication with sites to: manage ongoing project expectations and issues; ensure site compliance, adequate enrollment, and understanding of study requirements; and respond to site questions on study procedures/protocol.Assist in the development of site specific recruitment, retention and follow up plans.Monitor study participant progress, including documentation and reporting of adverse events; recommend corrective action as appropriate.Collect, review, maintain and track necessary regulatory documentation and essential study start-up and protocol documents from assigned sites in accordance with gGCPs, ICH guidelines, Company SOPs and relevant Regulatory body requirements.Ensure site and IRB/ EC SOPs and procedures are aligned with Corporate SOPs, Policies and gGCP and ICH regulations.Monitor all aspects of study related data for assigned study sites; including reviewing CRFs, protocol deviations and safety reports.Track all SAEs and AEs reported at assigned sites, ensuring proper documentation and reporting between site, IRB/ EC, sponsor and relevant regulatory bodies.Encourage site to enter study data to the case report form in a timely manner (per agreed upon timeline) and conduct SDV in a timely manner based on study requirements.Encourage site to enter study data to the case report form in a timely manner (per agreed upon timeline) and conduct SDV in a timely manner based on study requirements.Support site files and site staff for Regulatory inspections for assigned sites.Support development of study contract and study budget for assigned sites, as needed.Obtain the delegation of authority (DOA) list and/or sub-investigator & collaborator list of roles and responsibilities for site staff, confirm updates are applied when needed.Review clinical study documents, including study protocols, and provide feedback as pertinent to clinical monitoring.Conduct risk assessment categorization activities with cross-functional study team, including protocol- and site-level risk assessments.Review monitoring plans and provide feedback to study team.Perform remote data review and assign action plans, as required.Evaluate CRA quality and performance via periodic co-monitoring visits.Participate in CRA training activities across the Client/DSP organization. Education/Experience Requirements:Bachelor's degree from a four-year university or college; and five to seven years work experience in the healthcare or clinical trial industry, with a minimum of two years monitoring GCP clinical trials as a Clinical Research Associate (CRA) and a minimum of one year as a CRA Manager, Lead CRA or Project Manager; or equivalent combination of education and experience.Possesses a fundamental understanding of clinical development principles, theories and concepts and knowledge of pharmaceutical industry practices and standards, including GCP.Familiarity with the lifecycle of a clinical trial: from protocol development and feasibility through study close-out and reportingExcellent 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.Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists.Must be tactful, mature, flexible, and have well-developed interpersonal skills. Ability to get along well with different personalities and to work well in teams.Must have demonstrated ability to work independently and in a team, and provide leadership in a management role.Must have experience interfacing and managing multiple vendors/ contractors.Ability to manage time, multi-task and prioritize in order to complete deliverables on schedule.Computer skills needed include strong knowledge of database and word processing: MS Word, MS Project, PowerPoint, and Excel. 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.
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