Senior Clinical Research Manager
Job Description:
• Accountable for the delivery of studies or programs that are critical to a product’s clinical development, ensuring completion on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines
• Performs all required management responsibilities including implementing the company's policies, programs, and guidelines; ensuring employee productivity and growth; managing resources; knowing Varian's business; and maintaining functional, technical, and external market awareness necessary for managing immediate organization
• Communicate study status, cost and issues to ensure timely decision-making by senior management
• Initiate and manage study-level timelines, including communication to internal and external team members on deliverables
• Oversee the creation of site materials including training, manuals and support documentation
• Perform periodic review of clinical data, quality metrics and study deviations
• Develop timelines and budgets for assigned studies/programs and responsible for delivery to both quality and agreed timelines
• Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones
• Provides input into the development of study protocols and CRFs to ensure studies are designed and planned to be achievable
Requirements:
• Bachelor's degree in related field; minimum of 6 years of clinical operations experience in industry or CRO setting
• 3+ years of management experience
• Exceptional communication and interpersonal skills
• Excellent written and oral communication skills
• Knowledge of national / regional clinical trial regulations and industry standards regarding interactions with healthcare professionals essential
• Wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
Benefits:
• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan
• life insurance
• long-term and short-term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time
Apply Now
Apply Now
• Accountable for the delivery of studies or programs that are critical to a product’s clinical development, ensuring completion on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines
• Performs all required management responsibilities including implementing the company's policies, programs, and guidelines; ensuring employee productivity and growth; managing resources; knowing Varian's business; and maintaining functional, technical, and external market awareness necessary for managing immediate organization
• Communicate study status, cost and issues to ensure timely decision-making by senior management
• Initiate and manage study-level timelines, including communication to internal and external team members on deliverables
• Oversee the creation of site materials including training, manuals and support documentation
• Perform periodic review of clinical data, quality metrics and study deviations
• Develop timelines and budgets for assigned studies/programs and responsible for delivery to both quality and agreed timelines
• Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones
• Provides input into the development of study protocols and CRFs to ensure studies are designed and planned to be achievable
Requirements:
• Bachelor's degree in related field; minimum of 6 years of clinical operations experience in industry or CRO setting
• 3+ years of management experience
• Exceptional communication and interpersonal skills
• Excellent written and oral communication skills
• Knowledge of national / regional clinical trial regulations and industry standards regarding interactions with healthcare professionals essential
• Wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
Benefits:
• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan
• life insurance
• long-term and short-term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time
Apply Now
Apply Now