Keith Mickelberg Email & Phone Number

Philadelphia, PA, US

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Headquartered in Nottingham, UK, Calyx is a globally recognized provider of eClinical and regulatory solutions and services to biotech and CRO customers, including Medical Imaging (MI) Interactive Response Technologies (IRT), Electronic Data Capture (EDC) and Regulatory Information Management (RIM). Managed the global customer experience (Cx) organization.

Philadelphia, Pennsylvania, United States

Headquartered in NYC, Medidata is a leading provider of SaaS and data analytics solutions that support clinical research. Key product focus was the RAVE EDC platform and Patient Cloud Clinical Outcomes Assessment (eCOA). Developed and directed the customer experience (CX) strategy and department operations, overseeing all post-sales activities, including.

Philadelphia, Pennsylvania, United States

• Responsible for the customer success strategy for 3 top clients delivering clinical technologies including Medidata Rave EDC platform, Patient Cloud (eCOA), Medidata AI, and leading integration with the client’s.
• Managed the client account relationships ensuring delivery of quality projects and services across technical services, support services, product management, regulatory and compliance, training, and information.
• Provided leadership for the delivery of pre- and post-sales services and support managing all facets of customer retention (CRM), including resolving customer concerns and defining and developing a customer contact.

Headquartered in Philadelphia, and now known as Clario. A global eClinical and SaaS provider of clinical trial management software, devices and services including Cardiac Safety (ECG), eCOA, Medical Imaging and Forced Spirometry. Directed the relationships and account management of 5 key client accounts, including more than 160 studies and 5 service lines.

Philadelphia, PA

• Led the development of client relationships for 3 large-scale enterprise clients, focusing on managing all project/study activity associated with collection, analysis and reporting in clinical trials.
• Developed and drove all customer relationships from the hand-off "implementation" Project Manager, discontinuation of each customer's project lifecycle, and post-completion support.
• Ensured thorough review and verification that the product deliverable meets the customer's and contractual business specifications, including timeliness and quality.
• Coordinated with the Business Development Team to manage the scope of contract specifications and ad-hoc client requests to build and maintain client satisfaction.
• Supported project managers to meet their expectations and deliver high-quality products and services and trained new project managers on customer expectations, business/technical environments, priorities, and strategic.

Philadelphia, PA

• Managed the delivery of up to 10 multi-product studies, including eCOA, Spirometry and ECG services to ERT’s pharmaceutical and biotech clients, overseeing global Phase III studies across hundreds of trial sites and.
• Directed clinical trial activities to meet multi-million dollar contracts and timelines of cardiac safety and respiratory protocols in late-phase global clinical trials as well as phases I-II for additional clients.
• Reviewed and approved clinical trial contracts in conjunction with client protocols prior to the Project Manager's assignment of trials and assisted in the turnover of the sales to services turnover process.
• Led the planning, setup, monitoring, and close-out phases of eCOA study management, from requirements gathering, software development, and product delivery, to training, equipment distribution, and clinical.
• Coordinated with pharmaceutical companies, clinical trial sites and CROs in all phases of drug development, including training site personnel at national and international investigator meetings.
• Identified and documented potential study risks, developed effective risk mitigation strategies, conducted intermittent risk reviews, managed risk profiles throughout the study lifecycle, and escalated when appropriate.

• Oversaw project management for 16 ECG and 2 Spirometry studies, including the internal/external negotiations, trial planning, trial setup, trial maintenance and trial close-out activities, serving as the primary point.
• Managed client relationships, serving as primary point-of-contact, to support the client’s strategy to execute the plan for global clinical studies across hundreds of sites in the US, South America, and the EU for.
• Utilized ERT Project Assurance methodology for project management, coordinating required and optional internal and external project meetings during all study phases, including kick-off, setup, maintenance, and close-out.
• Ensured study documentation was per SOPs and quality standards; authorized release of electronic solutions upon completion of documentation review.
• Completed all Project Assurance required documentation, including Data Setup Specifications, Meeting Agendas and Minutes, Investigator Meeting Presentations, Training Manuals, Project Plans and Archiving Logs.
• Coordinated the type of Portal access and use for internal and external study personnel for all ERT studies during the development stages of the Portal system.

Philadelphia

• Directed the regulatory, data collection, clinical monitoring, training and close-out activities of threeNIH-NIDDK funded clinical research networks.
• Responsibilities included protocol writing and development, creation of standardized informed consent templates for IRB submission, monitoring of all regulatory (IRB) documents for sites, patient recruitment planning.
• Provided ongoing training and education to all participating study personnel.
• Planned, coordinated and directed quarterly steering committee meetings for an average of 45 attendees.
• Managed, coordinated and led the activities and deliverables of 7 internal employees.
• Provided support to manuscript writing team (pre-publication) and track all accepted manuscripts(post-publication).

• Coordinated and managed regulatory and clinical affairs of Hepatitis C and liver transplant protocols for Department of Hepatology clinical research site.
• Developed patient recruitment and retention strategies for study enrollment.
• Consented and enrolled study participants in various research protocols, supported documentation for IRB cycles.
• Collaborated with PI to manage side effects of study treatments, monitor and report Adverse Events.
• Interacted with study monitors to maintain GCP and quality data records.
• Redesigned the local archival of study source documentation.

United States

NIH funded AIDS clinical trials center focusing in HIV, HIV/HCV co-infection. Supported multiple early stage drug development clinical trials for HIV, HIV/HCV coinfected patients. Skills included recruitment, consenting, enrollment, and management of critically ill patients in clinical trials. Adverse event management, study drug management, specimen.

Education record

Bachelor'S Degree, Nursing