Mgr, Clinical Operations - CRA Line Management + CRA Monitoring ; Home-Based

Job Summary

MGR, Clinical Operations - CRA Line Management + CRA Monitoring Experience Required. Home‑Based, United States. Accountable for and provides management support and direct supervision to Clinical Operations staff including site selection support, site contract support, regulatory/ethics submissions, site activities including site activation and on‑site monitoring and/or central monitoring through study close out. Provides training, consultation and oversees metric compliance and quality related to operating activities of assigned staff to ensure project deliverables are met.

Collaborates and oversees the Clinical Operations Team to ensure fulfillment of customer requirements and compliance with related regulations.

• Line management of Clinical Operations staff: interviewing, selection, termination, professional development, performance appraisals, employee counseling; assign project work and review workloads for all direct reports.
• Review staff workloads and manage resource availability; ensure projects are suitably resourced and staffing needs are identified timely.
• Provide operational oversight and guidance to prioritise activities, review and monitor work performed, metric compliance and develop contingency plans.
• Assist in recruiting new staff, participate in interviews, onboarding; work to retain staff and maintain turnover rates within expected levels.
• Ensure quality and adherence to SOP/WIs, ICH GCP, federal/local guidelines; ensure all staff complete required training and documentation; provide regular updates to management.
• Work closely with business units/regions to ensure staff performance on studies; correct deficiencies; contribute to business unit level process improvements; may provide business development support.
• Conduct sign‑off and assessment visits to ensure Clinical Operations on‑site performance; develop and oversee training plans; maintain training records.
• Organise and chair clinical staff meetings; manage issues and follow up action items.
• Facilitate and support project/country reviews; focus on budget, schedule, risk analysis; use systems, reports, dashboards to identify performance issues, process gaps and monitor progress; oversee quality control efforts of assigned teams.

• Bachelor’s degree in life sciences, nursing, or equivalent plus extensive clinical research experience in a CRO, pharmaceutical or biotechnology company, with leadership experience.
• Extensive knowledge of GCP/ICH guidelines and other regulatory requirements.
• Excellent communication, presentation, interpersonal and change‑management skills.
• Strong time management, technical and organisational skills; ability to work independently and in team.
• Knowledge of basic financial concepts related to forecasting and budgeting; understands project budgets.
• Good computer skills and ability to embrace modern technologies.
• Ability to travel up to 25%.

The Company is committed to compliance with the Americans with Disabilities Act, including providing reasonable accommodations when appropriate, to assist employees or applicants to perform the essential functions of the job. The Company is committed to equality under the law and regulations worldwide, including the EU Equality Directive.