Senior Manager, Central Monitoring
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Job Description
Senior Manager leading Central Monitoring activities for clinical development studies in the biotechnology sector. Responsible for data analysis, reporting, and collaborating with study teams.
Responsibilities:
- accountable for centralized monitoring activities for global and/or complex trials
- analytical data review of key risk and/or operational performance data
- present as an integral member of the Clinical Study team for clinical development studies
- responsible for development and authoring activities of the Central Monitoring Plan
- participate in the Quality Risk and Control Tracker (QRACT) development
- work with data analysts in the technical configurations, implementation, and execution of Central Monitoring RBQM system across studies
- document the output from Central Monitoring Review meetings and track decisions/actions
Requirements:
- a minimum of a Bachelor’s degree
- at least 8 years of relevant experience in the biotechnology/pharmaceutical industry
- minimum 3 years with direct Central Monitoring experience
- proficiency and experience with CluePoint or similar RQBM system for Central Monitoring
- problem solving abilities, troubleshooting and resourcefulness
- analytical problem-solving experience
- working knowledge of clinical drug development process, ICH, GCP guidelines, and regulations
- effective communication and interpersonal skills; ability to build relationships internally and externally
- demonstrates writing skills to deliver messages effectively
- proficiency in Microsoft Office applications
Benefits:
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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