Central Monitoring Operations Manager
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Job Description
Clinical trial monitoring manager overseeing site strategy, risk detection, and compliance for clinical research trials. Safeguarding patient safety, data integrity, and trial outcomes in Bulgaria.
Responsibilities:
- Identify and characterize issues and trends in operational and patient clinical trial data using analytical or statistical tools
- Evaluate issues and develop findings based on analyzed data
- Communicate issues and potential risks to project team members for follow-up action
- Participate in risk mitigation strategies
- Own site monitoring strategy and oversight, including authoring risk assessments and monitoring plans
- Ensure effective sponsor oversight, trend analysis, and signal detection
- Provide site monitoring expertise to the trial team and lead implementation of monitoring and oversight approaches
- Oversee planning, execution, and issue management of site monitoring activities across all R/OPUs
- Ensure compliance with protocol, ICH-GCP, and regulatory requirements
- Maintain inspection readiness
- Safeguard patient safety, data integrity, and trial outcomes through monitoring oversight
Requirements:
- University or comparable degree in life sciences or related field, OR several years of equivalent professional education acceptable when complemented by solid knowledge and experience with Site Monitoring and Site Management processes and accountabilities
- 3+ years of previous experience providing the knowledge, skills, and abilities to perform the job
- Strong communication skills in complex cross-functional matrix structures
- Demonstrated Accountability Agility Intrapreneurship (AAI) approach and skills
- Ability to articulate and align business strategy/plan on an ongoing basis
- Active listening skills and cultural awareness
- Scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution
- Experience with trial complexity involving protocols, patients, sites, countries, and vendors
- Leadership skills for addressing complex situations and coordinating and overseeing teams
- Ability to support, connect, and empower teams and set priorities
- Good knowledge of English language and grammar
Benefits:
- Fully remote work arrangement
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