Job Summary: * Manage the day-to-day activities necessary for the successful completion of clinical programs according to company Standard Operating Procedures, ICH Guidelines and GCP. * Line management/mentoring responsibility. May serve as a supervisor for junior clinical staff. * May have some site monitoring responsibility. Responsibilities: * All aspects of designated clinical protocol(s) with accountability for meeting timelines, budgets and quality standards. * Anticipates project requirements and institutes appropriate actions to ensure timelines and project goals are met. * Oversight of designated activities outsourced to CROs, external consultants, central and specialist labs and other vendors * Provide status reports and acts as primary contact for management regarding project activity. * Manage the development of clinical trial protocols, case report forms, clinical trial reports and other clinical documents, as required. * Review, develop and implement all operational and project plan(s) for assigned studies. * Serve as point of contact for internal departments and external vendors * Develop the Monitoring Plan and ensure appropriate quality and timely monitoring of clinical sites. * Review trip reports and other aspects of site monitoring including, performance metrics and quality. Identify, troubleshoot and resolve issues pertaining to site monitoring for in-house and CRO monitored studies. * Oversee study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation. * Manage clinical follow-up of quality assurance audit reports. * Organize and conduct investigators' meetings. * Manage individual and team performance standards. Identify training, development and recognition needs of project team. * May conduct pre-study, initiation, routine monitoring and closeout visits of study sites, when necessary. Education/Qualifications Required: * University/college degree (life science preferred) * Thorough knowledge of CRFs, ICH Guidelines, GCP and the clinical trial process. * Insight of study budget process including: * Vendor and Investigator agreements and contracts. * CRO budgets, invoicing and payments * Site budgets and payment administration * Understanding of data management, statistical programming and regulatory affairs sufficient to perform project management responsibilities. Experience Required: * Minimum 7-years of relevant pharmaceutical industry experience including demonstrated skills and competency in monitoring and clinical project management tasks. * Ability or potential to manage clinical projects with minimum supervision. * Ability to work within a project team and lead or potential to lead a project team. * Ability to train / supervise and mentor junior staff. * Good planning and organizational skills. * Excellent verbal and written communication skills. * Good computer skills with good working knowledge of a range of computer packages.
To find out more about Real please visit
www.realstaffing.com [1]
Links:
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[1]
http://www.realstaffing.com 