Manager, Clinical Operations FSP – EMEA

This is a fully remote position, open to applicants in Bulgaria, +2 more countries.

📋 Description

• Supervise, train, allocate resources, coach, and manage the performance of a clinical operations-oriented team.

• Drive performance by utilizing metrics and key performance indicators.

• Address performance issues and identify training needs.

• Work in partnership with leadership to determine resource requirements.

• Oversee staff management and provide coaching, mentorship, and guidance.

• Conduct performance evaluations, facilitate career discussions, and promote employee development.

• Interview, recruit, and select new team members.

• Administer induction and orientation programs for incoming employees.

• Maintain staff CVs, training logs, position descriptions, and experience records.

• Ensure timely and accurate submission of timesheets and expense reports.

• Assist with allocation tasks and collaborate with project/functional leaders to enhance project operations.

• Highlight issues that may impact project deliverables.

• Provide training on WPDs, SOPs, local regulations, and clinical operations.

• Identify training deficiencies and ensure all training requirements are fulfilled.

• Ensure compliance with ethical and regulatory standards.

• Notify management of quality concerns and facilitate quality assurance audits.

• Review clinical operations systems such as Activate, CTMS, Preclarus, and Clarity to assess metrics, KPIs, and project progress.

• Assess the work of staff, including remote or on-site PAVs.

• Engage in process improvement endeavors.

• Ensure comprehension and implementation of risk-based monitoring.

• Provide contributions to bids and business procurement as needed.

• Collaborate with senior management and executive personnel on strategic planning and business growth.

• Lead or participate in department and company-wide initiatives aimed at performance or process improvement.

⛳️ Requirements

• Prior experience equivalent to 5+ years.

• At least 1 year of leadership experience.

• Equivalency through relevant education, training, and/or directly related experience may be considered.

• Advanced mentoring, leadership, and supervisory abilities.

• Exceptional clinical trials monitoring skills, both remote and on-site.

• Capability to learn and implement company SOPs, WPDs, and pertinent regulations, including ICH/GCP and FDA guidelines.

• Proficient in evaluating medical research data.

• Strong organizational and negotiation capabilities.

• Keen attention to detail.

• Advanced written and verbal communication skills.

• Good command of the English language and grammar.

• Proficient in computer operations, including data entry, archiving, and retrieval.

• Willingness to travel as required.

• Team-building, interpersonal, and conflict resolution skills.

• Advanced problem-solving abilities in a dynamic environment.

• Understanding of medical/therapeutic areas and medical terminology.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Work environment focused on scientific excellence.