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Senior Manager, Training & Development (Clinical Research)

Alcanza Clinical Research

Lake Mary, Florida(remote)

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JOB DETAILS
SKILLS
Analysis Skills, Business Support, Career Counseling, Clinical Research, Clinical Support, Communication Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Data Analysis, Data Quality, Dermatology, Documentation, Electronic Data Capture (EDC), FDA (Food and Drug Administration), FDA Requirements, GCP (Good Clinical Practices), HIPAA (Health Insurance Portability and Accountability Act), ICH Regulations, Identify Issues, Internet Application, Interpersonal Skills, Lead Generation, Maintain Compliance, Medicine, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Product Family, Microsoft SharePoint, Microsoft Word, Multitasking, Neurology, Onboarding, Operational Strategy, Organizational Skills, Patient Safety, People Management, Performance Metrics, Performance Reviews, Presentation/Verbal Skills, Problem Solving Skills, Project/Program Management, Psychiatry and Mental Health, Reporting Skills, Risk Analysis, Social Media Optimization (SMO), Society of Clinical Research Associates (SoCRA), Staff Training, Standard Operating Procedures (SOP), Standards Development, Time Management, Training Program, Training Program Development, Training/Teaching, Workforce Planning, Writing Skills, eLearning
LOCATION
Lake Mary, Florida(remote)
POSTED
1 day ago

Description


Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.

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. 

Key Responsibilities


Essential Job Duties:  
  • 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 
  • Develop 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 
  • Support growth, scalability, and decentralized trial models 
  •  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.
  • Perform other duties, responsibilities, and special assignments as requested or assigned in support of business needs.
  •  business, and company information at all times, using sound judgment when handling sensitive or time-sensitive matters.

Skills, Knowledge and Expertise


Minimum Qualifications: 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.

Required Skills: 
  • Proficiency with Microsoft applications (Word, Excel, Outlook, Teams, Sharepoint, and PowerPoint), email, web applications, and the ability to type proficiently (45+ wpm)
  • Must possess 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.
  • Must be professional, respectful of others, self-motivated, and have a strong work ethic.
  • Must possess a high degree of integrity and dependability.
  • 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.

About the Company

A

Alcanza Clinical Research

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