Manager, Clinical Operations – Southeast Region

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

📋 Description

• Oversee, select, train, resource, coach, and manage performance evaluations for clinical operations personnel.

• Utilize metrics and key performance indicators to oversee performance management.

• Lead or participate in initiatives aimed at enhancing departmental performance and improving company processes.

• Work alongside senior management and executive staff on strategic planning and business development efforts.

• Serve as the escalation point for performance issues and training requirements.

• Collaborate with leadership to address resourcing needs.

• Provide coaching, mentorship, and guidance on work direction.

• Conduct performance reviews and career discussions; promote career development opportunities.

• Interview, recruit, and select candidates for staff positions.

• Manage orientation and induction programs for newly hired employees.

• Keep staff CVs, training records, position descriptions, and experience profiles up to date.

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

• Assist in resource allocation and project/functional leadership tasks.

• Raise concerns regarding issues that could impact project deliverables.

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

• Identify any training gaps and ensure all requirements are fulfilled.

• Uphold ethical and regulatory standards in all operations.

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

• Analyze data from Activate, CTMS, Preclarus, and Clarity systems to assess employee and project metrics, KPIs, and project status.

• Review staff performance, including both remote and on-site PAVs.

• Support risk-based monitoring and process enhancement initiatives.

• Assist in bidding and procurement processes for new business as necessary.

• Interpret and implement policies, processes, and procedures effectively.

• Participate in and deliver presentations at both internal and external meetings.

• Address and resolve operational and scheduling challenges.

⛳️ Requirements

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

• Minimum of 5 years of relevant experience.

• At least 1 year of leadership experience.

• Consideration may be given for equivalency through a blend of appropriate education, training, and/or directly related experience.

• Advanced mentoring, leadership, and supervisory capabilities.

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

• Familiarity with or ability to quickly learn SOPs, WPDs, and pertinent regulations, including ICH/GCP and FDA guidelines.

• Capability to assess medical research data effectively.

• Strong organizational, negotiation, and problem-solving abilities.

• Exceptional attention to detail.

• Advanced written and verbal communication proficiency.

• Solid understanding of the English language and grammar.

• Computer literacy for data entry, archiving, and retrieval.

• Willingness to travel as necessary.

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

• Knowledge of medical/therapeutic domains and medical terminology.

• Consistent and regular attendance is required.

• Ability to work effectively under pressure and manage multiple tasks simultaneously.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• A global team environment.

• Frequent travel opportunities, both domestic and international.