Senior Manager, Learning & Development
Background
TrialSpark is a technology company that brings new medical treatments to patients faster by reimagining the clinical trial process. Today, a clinical trial can cost more than $100M and take 10 years to complete, bottlenecking the development of new treatments for patients.
Our company is using software and technology to streamline all aspects of a clinical trial. By reducing the time and cost it takes to run a clinical trial, we empower more treatments to be ultimately brought to patients.
TrialSpark’s business lines:
In short, TrialSpark works with our Biotech and Pharma partners in 3 ways: 1) we provide standalone digital advertising-based patient recruitment services, 2) we operate trial sites in support of phase II-IV clinical trials, and 3) we run end-to-end Phase II studies as an alternative to a Contract Research Organization (CRO).
Job Description
The Senior Manager, Learning & Development (L&D) Administration and Programming is responsible for enterprise administration of the learning management system (LMS), management of training delivery and compliance, and audit/inspection support in compliance with Good Clinical Practice (GCP), International Council for Harmonisation (lCH) guidelines, and US Health Authority regulations.
The Senior Manager consults with managers to identify educational needs and supports translation of these needs into effective learning and development programs based on new processes, corrective/preventive measures, key performance indicators, key quality indicators, risk management thresholds and overall business needs.
The Senior Manager is also responsible for managing and overseeing training compliance metrics, follow-up, and enforcement to secure compliance.
Responsibilities will include:
- Serve as owner and lead administrator for enterprise LMS migration, implementation, adoption and maintenance.
- Collaborate with managers and leadership to establish and/or maintain training curricula (including SOPs); assign relevant training programming through the LMS.
- Direct training delivery programming schedule and associated logistics.
- Represent L&D Operations during audit and inspection activities including providing necessary support, responding to relevant observations, and implementing and tracking to completing related corrective/preventive action plans as needed.
- Interview, evaluate, and select vendors for capabilities appropriate to the development/delivery of materials to meet the needs of learning and development initiatives; manage vendors and projects to meet project goals and to optimize timing and budgetary requirements.
- Schedule and perform compliance tracking and reporting; provide enterprise-wide support to maintain compliance, and escalate as necessary to secure compliance.
- Supporting any training projects and other department initiatives, as to include senior management special projects, corporate task forces, department team evaluations and interview programs; large cross functional training projects
- Define measures to assess, monitor, and report on the effectiveness and impact of training interventions as well as opportunities for improvement and refinement based on those metrics.
Experience
About You:
- Demonstrated understanding of Good Clinical Practice including pertinent FDA regulations and ICH E6 (R2) GCP Guideline.
- Proven ability to work in a cross-functional team environment with excellent interpersonal and communication skills.
- Ability to influence others through persuasive, logical, and constructive debate based on data.
- Keen analytical, prioritization, and multi-tasking skills with excellent attention to detail and follow through.
- Customer focus to build trust and develop solutions.
Required education and experience
- Bachelor's degree from an accredited institution is required, preferably in a health sciences or equivalent discipline.
- Minimum of ten (10) years of experience in the regulated pharmaceutical or healthcare industry.
- Experience with LMS administration and management of training curricula and delivery.
- Experience in the development and delivery of technical training programs.
Additional eligibility qualifications
- Good interpersonal and team player skills including ability to interact with a high degree of diplomacy with representatives from a variety of disciplines.
- Experience in multiple pharma industry environments including site management organizations, contract research organizations, as well as pharma/biotech.
- Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
- Self-motivated, self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
- Willing to accommodate up to 50% of travel.
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.