Ken Light Email & Phone Number

Mahwah, New Jersey, Us

Help emerging & mid-market companies accelerate growth and operational maturity by improving clinical, regulatory, and commercial outcomes. Leading TriRadial's global development consulting team focused on advancing clinical, safety, and regulatory domains, leveraging the following areas of expertise:• Process Optimization and Strategic Planning• Digital Transformation and Data Architecture• Clinical Innovation (patient engagement, automation, use of real-world data, and decentralized clinical trials)• eClinical Technologies (EDC, eCOA, CTMS, eTMF, patient portals, eConsent, IRT)• Computer Systems Validation Assurance and Regulatory Adoption

Newtown, Pennsylvania (Pa), Us

Available to help innovate and implement technologies used for clinical trials by sponsors, CROs, academic medical centers and other life sciences organizations. Deep experience delivering technology and strategy services to the clinical and drug safety communities. Available for:- Vendor product evaluations- Needs assessment / business requirements- Technology strategy and roadmap- Solutions architecture- Data architecture- Large scale project management- Product implementation- Industry presentations- Due diligenceExperience working with the majority of the top twenty pharmaceutical companies, along with numerous biotech, CROs, academic research centers and clinical sites. A passion for delivery excellence and customer satisfaction.

Ft. Lauderdale, Fl, Us

• Facilitate initiatives to drive business growth, operational efficiencies, client satisfaction, and quality improvements at a senior management level• Developed strategic vision and partnerships around virtual (decentralized) trials, EHR to EDC integration, and eSource• Established Transformation Services division offering technology, strategy and change management services to life sciences clients• Initiated transition delivery business model that enables customers to build and deploy clinical studies, lowering overall EDC cost of ownership• Oversaw US professional services teams in multiple locations including project management, EDC study development, implementation, training, and integration of eClinical and EDC solutions• Oversaw the integration activities related to acquisition of eClinical business unit and Acuity Analytics business unit• Oversee OmniComm's technology partnership program. • Launched new solution center in New Jersey to staff eClinical and Professional Services teams• Harmonized operations across two locations by merging organization and creating standard methodologies and SOPs• Originated global internal training program and committee• Established annual global user group forum and initiated strategic advisory board• Oversaw the design and development of an innovative eLearning solution • Oversaw system integration and data migration initiatives for customers• Helped sell, propose, and deliver large customer EDC projects. • Served as executive sponsor to multiple leading customers.• Helped define company cloud and eSource strategies. Sold first eClinical cloud hosting solution.

Us

• Oversaw delivery of services to major pharmaceutical companies focused on accelerating clinical development. • Initiated and oversaw projects including clinical data warehouse architecture and development, electronic data capture vendor selection, clinical site monitoring strategy, drug development process harmonization, clinical operations benchmark study, investigator initiation and patient recruitment acceleration, product master data strategy, and investigator portal strategy.• Developed a relationship with a top-twenty global pharmaceutical company and expanded into an $8 million annual account.• Initiated competency center that authored numerous white papers, presentations, training materials, and a web site focused on product development. • Expanded staff focused on clinical development by 400% in two years. • Developed significant, long-lasting new customer relationships within large biopharmaceuticals and increased market penetration with existing customers.

Austin, Texas, Us

• Oversaw "Oracle Clinical" National Consulting Practice – Supervised team that provides implementation of Pharmaceutical Applications to major pharmaceutical and life sciences organizations. • Responsible for $7 million business unit including staff, sales, delivery, contracts, and receivables. • Developed business solutions surrounding the Oracle Pharmaceutical Application suite including implementation and validation approaches, training strategies, custom software solutions, migration and consolidation methods, remote data capture tools, and project management methods.• Led project teams in the implementation of Oracle Clinical and Remote Data Capture in the areas of system architecture expertise, custom software extensions, global standards development, formal and custom training, application pilots, quality assurance, deployment, and project management.• Developed collaboration between Oracle and three top-ten pharmaceutical companies leading to the joint development of clinical software technology.

Us

• Held positions of increasing responsibility including Program Manager, Advisory Consultant, Client Services Manager, Practice Director, Client Partner. • Part of a management team that grew the organization from 90 people to 600 people over a six year period• Founding member of NJ business practice - Grew the NJ practice from 3 to 50 personnel in three years and ultimately 120 personnel. Supervisory responsibility for 25 individuals. • Oversaw $10 million of annual services to a single, top-ten pharmaceutical customer. • Worked with major pharmaceutical companies implementing clinical and safety technologies.• Established Centers of Excellence focused on clinical trial and adverse events IT solutions. • For a top-ten pharmaceutical company, designed and implemented a shared-services support model that provided ongoing off-site support services for clinical applications leading to $3 million of annual annuity revenue.• Developed and implemented pharmaceutical R&D software solutions including CTMS, CDMS, Adverse Event Systems, drug stability, regulatory tracking, clinical drug supply tracking, pre-clinical pharmacology. Migrated a SAS statistical computing environment containing 12,000 SAS datasets, programs, figures, and listings. • Developed software on several generations of technology platforms and a multitude of software development and reporting tools. • Utilized a variety of software development lifecycle methodologies and software engineering tools. • Developed a class and trained over 100 information technology associates in the “Introduction to the Pharmaceutical Industry”.

Bs, Accounting

Ms, Computer Science