Job OverviewPerform monitoring and site management work for a variety of protocols, site and therapeutic areas.Essential Functions• In addition to monitoring activities, the following activities are being performed:Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.Collect information on team performance against contract, customer expectations, and project baselines.Lead problem solving and resolution efforts to include management of risk, contingencies and issues.Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.Provide input to line managers of their project team members’ performance relative to project tasks.Prepare and present project information at internal and external meetings.Participate in proposal development and in the bid-defense process with guidance and supervision.Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team.Qualifications• Bachelor's Degree in scientific discipline or health care preferred.• Requires at least 3 years of on-site monitoring experience.• Equivalent combination of education, training and experience may be accepted in lieu of degree.• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.• Strong therapeutic and protocol knowledge as provided in company training.• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).• Written and verbal communication skills including good command of English language.• Organizational and problem-solving skills.• Effective time and financial management skills.• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
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