Manager, Clinical Operations

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

📋 Description

• Oversee the operations of the clinic while driving improvements in processes.

• Lead, support, mentor, and develop a team of professionals in Clinical Operations.

• Manage the entire employee lifecycle, encompassing recruitment, onboarding, goal setting, performance management, and career advancement.

• Conduct induction, orientation, performance evaluations, and skills assessment programs.

• Identify development needs and address any performance issues.

• Review and authorize time records, expenses, leave requests, and administrative tasks.

• Maintain precise employee documentation.

• Ensure successful execution of country-level clinical trials.

• Align team objectives and individual contributions with study deliverables, quality expectations, and business goals.

• Assist in staff allocation based on resource processes and study priorities.

• Collaborate with project and functional leaders to enhance operational performance.

• Escalate risks or issues that may impact timelines, quality, or deliverables.

• Provide training on SOPs, WPDs, local regulatory requirements, and operational topics.

• Identify training deficiencies and implement development strategies.

• Contribute to training programs and knowledge-sharing initiatives.

• Advocate for risk-based monitoring principles.

• Identify quality issues, request QA audits, and assist with audit responses.

• Contribute to initiatives focused on process improvement and operational excellence.

• Monitor KPIs, team performance, and study status utilizing applicable systems and tools.

• Administer policies, processes, and procedures affecting assigned sections and subordinate work units.

• Manage experienced clinical operations professionals while ensuring overall team performance, development, and operational delivery.

⛳️ Requirements

• Bachelor's degree or equivalent relevant formal academic/vocational qualification.

• Over 5 years of relevant experience providing the necessary knowledge, skills, and abilities for the role.

• At least 1 year of leadership experience.

• Strong leadership, coaching, mentoring, people management, and supervisory abilities.

• Extensive expertise in clinical trial operations and monitoring.

• In-depth knowledge of risk-based monitoring and quality management principles.

• Comprehensive understanding of ICH/GCP, company SOPs/WPDs, FDA guidelines, and relevant regulatory requirements.

• Familiarity with therapeutic areas and medical terminology.

• Ability to assess medical and clinical research data.

• Strong organizational, planning, prioritization, and resource allocation skills.

• Capability to anticipate risks, resolve complex problems, and escalate when necessary.

• Skills in continuous improvement and process optimization.

• Quality-focused negotiation and decision-making abilities.

• Proficiency in clinical systems and performance management tools.

• Advanced computer skills, including data entry, documentation management, and information retrieval.

• Excellent command of English, both written and spoken.

• Willingness and ability to travel as required.

🏝️ Benefits

• Global team environment.

• Opportunities for career development.

• Resources available to achieve individual career objectives.

• Opportunities for collaboration and professional development.

• Meaningful work that contributes to life-changing therapies and enhanced health outcomes.