Clinical Research for All℠
Senior Manager, Training & Development – Clinical Research
Location
Florida
Posted
5 days ago
Salary
0
Seniority
Senior
Job Description
Senior Manager, Training & Development – Clinical Research
Alcanza Clinical Research
• 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.
Job 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.
- 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.
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