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 problems and generate findings based on the analyzed data.

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

• Engage in strategies aimed at risk mitigation.

• Manage the site monitoring strategy and oversight, which includes creating risk assessments and monitoring plans.

• Ensure effective oversight from sponsors, trend analysis, and signal detection to enhance trial quality and delivery.

• Offer site monitoring expertise to the trial team.

• Lead the execution of monitoring and oversight strategies.

• Supervise the planning, execution, and issue management of site monitoring activities across all R/OPUs.

• Ensure adherence to protocol, 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 in life sciences or a related field, or several years of equivalent professional education is acceptable when paired with substantial knowledge and experience in Site Monitoring and Site Management processes and responsibilities.

• A minimum of 3 years of relevant prior experience.

• Strong knowledge and experience in Site Monitoring and Site Management processes and responsibilities.

• Excellent communication skills within complex cross-functional matrix structures.

• Ability to effectively articulate and align business strategies and plans consistently.

• Active listening skills combined with cultural sensitivity.

• Scientific and therapeutic knowledge, along with operational expertise in Site Monitoring aspects of clinical trial planning and execution.

• Understanding of trial complexity dimensions, including protocols, patients, sites, countries, and vendors.

• Leadership and influence skills to navigate complex situations and coordinate teams effectively.

• Capability to support, connect, empower teams, and prioritize tasks.

• Proficiency in the English language and grammar.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.