Symbio, LLC is a small and slow growing Contract Research Organization. We are currently in search of a full-time, Home Office-Based, Training and Development Manager to join our Symbio team. The qualified candidate will be responsible for development and execution of training programs for recruitment, growth and development of Clinical Operations employees and contractors in collaboration with department heads within Clinical Operations. This position will involve travel.
Develop and implement entry level training program, as well as function-specific training programs for all Clinical Operations staff.
Develop entry level training program specifically for CRAs to efficiently and effectively onboard newly experienced CRAs in order to meet Symbio business objectives.
Develop and manage an effective and efficient comprehensive onboarding and orientation program for all new hires in clinical operations (employees and contractors)
Lead in process development and improvement on current processes by developing tools, such as process maps, guidelines, etc. or SOPs across the clinical operations departments
Recruit clinical operations staff including developing recruitment plans and strategies in collaboration with HR Manager to implement plans, schedule and conduct interview exercises with selected candidates, collaborate with Management on selection of qualified candidate(s) for hire
Supports audits and inspections
Reviews SOPs on a routine basis and revises SOPs, process maps, forms, templates, guidelines and supporting documentation when appropriate to ensure compliance with regulatory requirements
Works with Document Control to support maintenance of SOPs, Working Practices and related documents
Monitors the impact of any business process or regulatory changes on SOP documentation and makes the appropriate recommendation
Bachelor’s Degree or higher (life sciences preferred)
10+ years CRO/Clinical Operations experience
4+ years managing and mentoring staff in a training and development position within Clinical Operations
Prior experience working in a risk based approach environment
Prior experience with learning management systems
Maintains knowledge of current industry trends, standard and methodologies and is well versed in FDA/ICH GCPs, the clinical trial process, critical elements for trial success
Excellent planning and organization skills
Proven experience successfully leading cross functional teams in SOP and training
Self-starter with the ability to independently multi-task efficiently and prioritize work load
Strong communication and presentation skills demonstrating ability to influence and implement change effectively
Proficiency in Microsoft Word, Excel, and PowerPoint
Internal Number: 20180622
About Symbio, LLC
Symbio, LLC is a small but busy and vibrant Contract Research Organization based out of Port Jefferson, NY. Our services are extensive and complete, and range from the following:Pre-Study, including Protocol Development, Site Identification and Qualification, Study Planning and Set-up, Regulatory Collection and IRB Submission, and Coordinate Investigator Meetings; Study Management, including Study Initiation, Ongoing Communication, Monitoring Visits and Reports, and SAE Notification; and Post-Study including, Data Management/Statistics, Final Reporting, and Document Archiving. At Symbio, our motto is…Exceeding Expectations in Clinical Trials.