Senior Manager, Training & Development (Clinical Research)
hace 19 días
Lake Mary
Job DescriptionDescriptionAlcanza 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 ResponsibilitiesEssential 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 ExpertiseMinimum 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.