Central Monitoring Operations Manager

This is a fully remote position, open to applicants in Bulgaria.

📋 Description

• Identify and analyze issues and trends in operational and patient clinical trial data utilizing analytical or statistical tools.

• Assess issues and form conclusions based on the analyzed data.

• Communicate identified issues and potential risks to project team members for necessary follow-up actions.

• Engage in strategies for risk mitigation.

• Oversee the site monitoring strategy and supervision, including the creation of risk assessments and monitoring plans.

• Ensure effective oversight by sponsors, conduct trend analysis, and facilitate signal detection.

• Offer site monitoring expertise to the trial team and spearhead the implementation of monitoring and oversight strategies.

• Manage the planning, execution, and resolution of issues related to site monitoring activities across all R/OPUs.

• Guarantee compliance with protocols, ICH-GCP, and regulatory standards.

• Maintain readiness for inspections.

• Protect patient safety, data integrity, and trial outcomes through diligent monitoring oversight.

⛳️ Requirements

• A university degree or equivalent qualification in life sciences or a related field, or several years of relevant professional education complemented by substantial knowledge and experience in Site Monitoring and Site Management processes and responsibilities.

• A minimum of 3 years of prior experience providing the necessary knowledge, skills, and abilities to fulfill the job requirements.

• Strong communication abilities within complex cross-functional matrix environments.

• Proven skills and approach in Accountability Agility Intrapreneurship (AAI).

• Capability to consistently articulate and align business strategies/plans.

• Active listening skills complemented by cultural sensitivity.

• Scientific and therapeutic expertise alongside operational knowledge across all aspects of Site Monitoring in clinical trial planning and execution.

• Experience handling trial complexity involving protocols, patients, sites, countries, and vendors.

• Leadership abilities to address complex situations while coordinating and supervising teams.

• Capacity to support, connect, and empower teams while establishing priorities.

• Proficient knowledge of the English language and grammar.

🏝️ Benefits

• Fully remote work arrangement.