Senior Manager, Training & Development (Clinical Research)

About the role

The Sr. Manager, Training & Development leads the design, implementation, and scaling of clinical research training programs, aligned with strategic, operational, and quality objectives, across our multi-site clinical research network.

Responsibilities

• Partner with VP, Strategic Operations to align training with enterprise priorities and KPIs, translating strategic goals into scalable training programs
• Support workforce planning, capability building, and operational standardization
• Create and execute a network-wide training strategy and program development
• Create standardized onboarding and role-based training for site staff (CRCs, investigators, site managers, etc.)
• Design curricula for: GCP, ICH guidelines, and compliance, Protocol execution and study conduct, Source documentation (ALCOA+), Regulatory documentation and inspection readiness, E/SAE reporting and patient safety
• Partner with Site Operations to identify performance gaps and deploy targeted training
• Improve site KPIs (enrollment, retention, protocol adherence, data quality)
• Drive consistency and reduce variability across sites
• Ensure training meets FDA, ICH-GCP, and sponsor requirements
• Maintain inspection-ready training documentation
• Support audits, inspections, and CAPA implementation
• Manage and optimize LMS for training compliance and tracking
• Implement scalable learning solutions (e-learning, virtual, microlearning)
• Support adoption of clinical technologies (CTMS, EDC, eReg) through training
• Lead and develop training personnel or site-based trainers
• Influence site leaders to adopt standardized training practices
• Promote a culture of continuous learning and quality
• Establish and track training KPIs (compliance, time-to-productivity, audit outcomes)
• Analyze data to improve training effectiveness and operational impact
• Provide regular reporting to VP, Strategic Operations
• Lead training for new SOPs, systems, and process changes
• Drive adoption of standardized practices across a distributed network
• Routinely assess study-specific process and training compliance and identifies emerging risks.
• May develop and support execution of corrective action plans at site and study level.
• Oversee people management activities including interviewing and selection, performance appraisals, job description preparation, employee counseling, and career coaching.
• Oversee payroll timecards, absence tracking/approvals, onboarding, and team training per operational needs.
• Participate, lead and/or present in management, training, department, site, and other meetings.
• Maintain strict confidentiality of employee, participant, customer, executive, board, business, and company information at all times, using sound judgment when handling sensitive or time-sensitive matters.

Requirements

• A Bachelor’s degree AND 8+ years of clinical research experience AND 3+ years of training and workforce development experience, OR an equivalent combination of education and experience, is required.
• 2+ years of management experience is required.
• Must have thorough knowledge of GCP, FDA regulations, and site operations.
• Certification in clinical research and/or training such as ACRP (CCRC/CCRA), SOCRA (CCRP), CPTD, or similar certification, is highly preferred.
• Experience in multi-site clinical research network or SMO is preferred.
• Experience with audits/inspections and site technologies is also preferred.

Qualifications

• Proficiency with Microsoft applications (Word, Excel, Outlook, Teams, Sharepoint, and PowerPoint), email, web applications, and the ability to type proficiently (45+ wpm)
• Strong organizational, time management and problem-solving skills
• Well-developed written and verbal communication skills
• Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, employees, managers, business leaders, and external customers
• Strong facilitation skills with prior experience presenting content to all levels of the organization
• Strong project management, analytical, and critical thinking skills
• Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities
• Ability to work under minimal supervision, identify problems and implement solutions
• Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines

Benefits

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

• Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.