Senior Manager, Training & Development – Clinical Research

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

📋 Description

• Collaborate with the VP of Strategic Operations to align training initiatives with organizational priorities and key performance indicators (KPIs), translating strategic objectives into scalable training programs.

• Assist in workforce planning, capability enhancement, and the standardization of operations.

• Develop and implement a comprehensive training strategy and program across the network.

• Design standardized onboarding and role-specific training for site personnel (Clinical Research Coordinators, investigators, site managers, etc.). Curriculum development includes:

• Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and compliance.

• Protocol implementation and study management.

• Source documentation (ALCOA+).

• Regulatory documentation and readiness for inspections.

• Reporting of adverse events and patient safety measures.

• Partner with Site Operations to pinpoint performance gaps and provide targeted training solutions.

• Enhance site KPIs such as enrollment rates, retention, adherence to protocols, and data integrity.

• Foster consistency and minimize variability across sites.

• Ensure training complies with FDA, ICH-GCP, and sponsor specifications.

• Maintain training documentation that is ready for inspection.

• Assist with audits, inspections, and the implementation of Corrective and Preventive Actions (CAPA).

• Manage and optimize the Learning Management System (LMS) for compliance and tracking purposes.

• Implement scalable learning solutions, including e-learning, virtual training, and microlearning.

• Facilitate the adoption of clinical technologies (CTMS, EDC, eReg) through training efforts.

• Lead and mentor training staff or site-based trainers.

• Encourage site leaders to adopt standardized training methodologies.

• Advocate for a culture of continuous learning and quality improvement.

• Establish and monitor training KPIs (compliance rates, time-to-productivity, audit results).

• Analyze data to enhance training effectiveness and operational results.

• Provide regular updates to the VP of Strategic Operations.

• Conduct training for new Standard Operating Procedures (SOPs), systems, and process modifications.

• Support growth, scalability, and decentralized trial frameworks.

• Promote the adoption of standardized practices across a distributed network.

• Regularly evaluate study-specific processes and training compliance while identifying emerging risks.

• May be responsible for the development and execution of corrective action plans at both site and study levels.

• Oversee personnel management tasks, including interviewing and selection, performance evaluations, job description creation, employee counseling, and career coaching. Manage payroll timecards, absence tracking/approvals, onboarding, and team training as operational needs dictate.

• Actively participate in, lead, and/or present at management, training, department, site, and other meetings.

• Maintain strict confidentiality regarding employee, participant, customer, executive, board, business, and company information at all times, exercising sound judgment in handling sensitive or urgent matters.

• Perform additional duties, responsibilities, and special projects as requested or assigned to support business needs.

⛳️ Requirements

• A Bachelor’s degree and a minimum of 8 years of clinical research experience, along with at least 3 years of experience in training and workforce development, or an equivalent combination of education and experience, is required.

• A minimum of 2 years of management experience is required.

• Comprehensive knowledge of GCP, FDA regulations, and site operations is essential.

• Certification in clinical research and/or training (such as ACRP (CCRC/CCRA), SOCRA (CCRP), CPTD, or similar) is highly preferred.

• Experience working within a multi-site clinical research network or Site Management Organization (SMO) is preferred.

• Familiarity with audits/inspections and site technologies is also preferred.

• Proficient in Microsoft applications (Word, Excel, Outlook, Teams, SharePoint, and PowerPoint), email, web applications, and capable of typing proficiently (45+ wpm).

• Strong organizational, time management, and problem-solving skills are necessary.

• Well-developed written and verbal communication abilities are required.

• Excellent interpersonal and listening skills, with the capacity to work effectively both independently and collaboratively with co-workers, employees, managers, business leaders, and external clients.

• Strong facilitation skills with prior experience presenting information to all organizational levels.

• Proficient project management, analytical, and critical thinking skills are essential.

• Ability to manage multiple tasks effectively and adapt to shifting workloads and priorities.

• Must demonstrate professionalism, respect for others, self-motivation, and a strong work ethic.

• High integrity and dependability are required.

• Ability to work with minimal supervision, identify issues, and implement solutions.

• Competency in handling highly sensitive information in a confidential and professional manner, in compliance with HIPAA guidelines.

🏝️ Benefits

• Full-time employees scheduled to work at least 30 hours per week are eligible for benefits, with coverage commencing on the first day of the month following their hire date.

• Benefits include medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401(k) plan with a safe harbor match.