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.
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.
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.
