Clinical Affairs Specialist *PC

Benefits

Qualifications

• •B.S. in a science-related discipline, e.g. biology, chemistry, biotechnology, biochemistry, molecular biology, or a similar discipline; 5+ years' experience in a similar role
• •Must be familiar with a wide range of clinical research and project management areas, including maintenance of complex schedules, document management, internal/external communications, and regulatory frameworks
• •Strong written and verbal communication skills
• •Ability to problem-solve and think critically
• •Understanding of the pharmaceutical and biotechnology industry
• •The employee must occasionally lift and/or move up to 25 pounds
• •Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus
• •Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail
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Responsibilities

• •This position is primarily responsible for managing projects and programs that support the development of Phase I cell therapies with our academic partners
• •This role will also be responsible for supporting the implementation of projects to PMO global standards, Miltenyi business processes, strategic initiatives, and best practices to meet project goals
• •Support the leadership team in the development of project alignment, with the portfolio, to business strategy, functional constraints, and resource proficiency
• •The role applies professional expertise and company policies to resolve issues, determine appropriate actions, and refine processes as needed
• •Aid in the execution of the Phase I clinical trials from protocol design to the final clinical study report
• •Execute high quality, integrated cross-functional plans for the project/clinical trial
• •Coordinate the activities of functional groups that comprise the clinical department team for the product including, but not limited to clinical monitoring, data management, statistics, medical writing, medical monitoring, and safety to insure proper conduct and timely completion of all projects
• •Apply best practices in the development, initiation, planning, execution, control and closing of projects
• •Manage resource shipments to clinical trial sites
• •Cross-functional planning throughout Miltenyi teams to ensure site readiness, including data review and working with local teams to arrange training
• •Troubleshoot technical difficulties at the clinical trial sites and leverage other expertise within the Miltenyi team
• •Manage quarterly meetings with and collect data from the clinical trial sites
• •Engage multiple Miltenyi groups, including additional R&D teams, Marketing, Regulatory, and Sales, to leverage the resources from the clinical trials to further grow the Miltenyi pipeline and support future sales efforts
• •Ensure project documents are complete, current, and stored appropriately
• •Create a positive environment by working collaboratively
• •Work with the team or project managers, program manager, and PMO to develop and maintain project KPI's and dashboards
• •The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job
• •Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
• •While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms, talk, and hear
• •The employee is required to sit and stand; climb or balance and stoop, kneel, crouch, or crawl
• •This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures
• •Generally, this job is performed in an office environment
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