Siemens Healthineers
We pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Senior Clinical Research Manager
Location
United States
Posted
18 days ago
Salary
$161.2K - $221.6K / year
Bachelor Degree6 yrs expEnglishGoogle Cloud Platform
Job Description
• Accountable for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines
• Performs all required management responsibilities including but not limited to: 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 is 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
Job 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
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