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 & take 10 years to complete, bottlenecking the development of new treatments for patients.
Our company is using software & technology to streamline all aspects of a clinical trial. By reducing the time & cost it takes to run a clinical trial, we empower more treatments to be ultimately brought to patients.
TrialSparks business lines:
In short, TrialSpark works with our Biotech & 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, & 3) we run end-to-end Phase II studies as an alternative to a Contract Research Organization (CRO).
The Senior Manager, Learning & Development (L&D) Administration & Programming is responsible for enterprise administration of the learning management system (LMS), management of training delivery & compliance, & audit/inspection support in compliance with Good Clinical Practice (GCP), International Council for Harmonisation (lCH) guidelines, & US Health Authority regulations.
The Senior Manager consults with managers to identify educational needs & supports translation of these needs into effective learning & development programs based on new processes, corrective/preventive measures, key performance indicators, key quality indicators, risk management thresholds & overall business needs.
The Senior Manager is also responsible for managing & overseeing training compliance metrics, follow-up, & enforcement to secure compliance.
Responsibilities will include:
- Serve as owner & lead administrator for enterprise LMS migration, implementation, adoption & maintenance.
- Collaborate with managers & leadership to establish and/or maintain training curricula (including SOPs); assign relevant training programming through the LMS.
- Direct training delivery programming schedule & associated logistics.
- Represent L&D Operations during audit & inspection activities including providing necessary support, responding to relevant observations, & implementing & tracking to completing related corrective/preventive action plans as needed.
- Interview, evaluate, & select vendors for capabilities appropriate to the development/delivery of materials to meet the needs of learning & development initiatives; manage vendors & projects to meet project goals & to optimize timing & budgetary requirements.
- Schedule & perform compliance tracking & reporting; provide enterprise-wide support to maintain compliance, & escalate as necessary to secure compliance.
- Supporting any training projects & other department initiatives, as to include senior management special projects, corporate task forces, department team evaluations & interview programs; large cross functional training projects
- Define measures to assess, monitor, & report on the effectiveness & impact of training interventions as well as opportunities for improvement & refinement based on those metrics.
- Demonstrated understanding of Good Clinical Practice including pertinent FDA regulations & ICH E6 (R2) GCP Guideline.
- Proven ability to work in a cross-functional team environment with excellent interpersonal & communication skills.
- Ability to influence others through persuasive, logical, & constructive debate based on data.
- Keen analytical, prioritization, & multi-tasking skills with excellent attention to detail & follow through.
- Customer focus to build trust & develop solutions.
Required education & 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 & management of training curricula & delivery.
- Experience in the development & delivery of technical training programs.
Additional eligibility qualifications
- Good interpersonal & 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 & able to prioritize & handle multiple tasks & 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.