Experience

Karuna Therapeutics

• United States
• Biotechnology
• 100 - 200 Employee

• Exc. Director, Clinical Operations

  • May 2019 - Present



MKS Pharma Consultants LLC

• Greater New York City Area

• President/Consultant

  • Sep 2017 - May 2019

  Providing consulting services to the Pharmaceutical and Biotech industry. Specializing in change management, preforming gap analysis and process improvement as well as clinical compliance, RFP review, CRO and vendor management. In the areas of Clinical Operations and Project Management with a focus on Study Start Up, Monitoring, Project Management, Quality Assurance, Trial Mater File Management and audit readiness as well as eTMF implementation. Providing consulting services to the Pharmaceutical and Biotech industry. Specializing in change management, preforming gap analysis and process improvement as well as clinical compliance, RFP review, CRO and vendor management. In the areas of Clinical Operations and Project Management with a focus on Study Start Up, Monitoring, Project Management, Quality Assurance, Trial Mater File Management and audit readiness as well as eTMF implementation.



Premier Research

• United States
• Biotechnology Research
• 700 & Above Employee

• Executive Director, Clinical Operations, Global Study Start Up & Document Management

  • Sep 2014 - May 2017

  •Overall responsibility for the leadership and management of the Study Start Up Group North America and Global Document Management TMF oversight•Overall responsibility for the leadership and management of Site Contracts •Ensures that the Study Start Up process is proactive and completed according to contractual agreement•Responsible for Study Start Up Metrics and Systems•Performs all aspects of managing/mentoring direct reports, training and performance management. Show less

• Director, Clinical Planning & Study Start Up

  • Sep 2012 - Sep 2014

  •Overall responsibility for the leadership and management of the Study Start Up Group •Overall responsibility for the leadership and managment of Site Contracts •Ensures that the Study Start Up process is proactive and completed according to contractual agreement•Responsible for Study Start Up Metrics and Systems•Performs all aspects of managing/mentoring direct reports, training and performance management.



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Manager, Clinical Operations

  • May 2011 - Sep 2012

  • Responsible for management of Clinical Operation’s activities and provide leadership in the implementation of PRA’s quality initiatives and business processes. • Oversight of CRAs as assigned. Manage and define goals to support the growth and career development of assigned staff. Provide on-going assessment of staff members, including quality of work, site management skills, leadership skills and training. • Responsible for quality visit assessments and assuring quality metrics are in line with company objectives. •Assist in quality review of internal and external audits reports. Assess clinical operation’s employee resources and resource projections to ensure project teams meet expectations. •Responsible for strategic management of Clinical Operation’s contractor needs and process, as well as assessing resourcing and placement of both CRA and project administrator contractors. Functions as legal representative between PRA and contracted vendors for execution of all Master Service Agreements. •Involved in directing and supporting Recruiting in identifying Clinical Operation, North American staffing needs for CRAs. Including therapeutic areas, regional location and candidate selection. Show less



Amicus Therapeutics

• United States
• Biotechnology Research
• 300 - 400 Employee

• Document Control Management

  • Jun 2010 - May 2011

  •Responsible for supporting GCP investigator, vendor and internal systems audits and inspections as required. •Developed and managed audit reports and CAPAs in conjunction with clinical operations. •Oversaw all aspects of set-up, maintenance, and archiving of all clinical trial related physical and electronic documentation, including the Trial Master File (TMF), in compliance with ICH-GCP, good documentation practices and company records management policies and procedures. •Responsible for managing the TMF contents in an audit ready state within Clinical R&D records management and oversee the design, implementation, and maintenance of processes and TMF documentation to an electronic records management system. •Additional responsibilities included, support of off-site archival needs for clinical R&D documentation, facilitate provision and tracking of SOP and GCP training, and keep executive management informed of training compliance performance metrics, review and provision of compliance input into GCP related policies and procedures. Show less



ZeeCRO, Inc (formally AAIPharma)

• CRA Manager

  • Jun 2007 - Apr 2010

  Responsible for supervision of CRAs as assigned. Manage and define goals to support the growth and career development of assigned staff. Provide on-going assessment of staff members, including quality of work, site management skills, leadership skills and training. Responsible for directing activities for assigned clinical study teams, including site management, recruiting, startup, maintenance, data collection and close-out of assigned studies. Interact with Project Management and Clinical Affairs management to determine staffing needs, personnel assignments, CRA performance and site management issues. Perform QC audit visits and co-monitoring visits as required. Assisted in developing a Project Management and Clinical Affairs Management alignment program, to aid in the communication of project progress and assessment. Responsible for overseeing and coordinating activities of the Clinical Document Management Group (Trial Master File). Show less



West-Ward Pharmaceuticals

• Manager, Regulatory Affairs

  • Jun 2005 - Oct 2005

  Responsible for compiling, reviewing and submitting annual reports, periodic ADE reports, 15-day alert reports and ANDA supplements. Coordinate eANDA submissions in Core Dossier. Acted as the regulatory liaison with the FDA on submission deficiencies, approvals and other issues. Oversaw Regulatory Affairs Associates in labeling revisions, SOP maintenance and development, compiling of FDA submission and other departmental activities. •Responsible for developing and moving FDA Submissions to electronic format. Show less



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Sr. Manager, Document Management

  • Dec 1999 - Jan 2005

  Responsible for overseeing and coordinating activities of the Document Management Department. Ensure that document management deliverables are completed and delivered within client contractual guidelines. Supervise, train and mentor Document Management staff to ensure cross-training and development of proficiency in all departmental activities. Oversee all aspects of set-up, maintenance and archiving of project file including the trial master file in compliance with ICH and GCP guidelines. Facilitate the implementation of global processes and focus on continual global process improvement and compliance within all regions of PRA Document Management worldwide. Coordinate the collection of quality management data, ensure accuracy of data collected and determine corrective action for defects found. •Developed and implemented global Document Management SOPs, process and departmental structure. •Assisted in the development, rollout and upgrade of a global Document Management system. •Responsible for managing the receipt of over 200,000 pages of clinical study documentation per month while simultaneously managing both the clinical and data aspects of clinical studies for up to 50 studies at a time. • Reorganized the Document Management Department developing it from a staff of three to seventeen. Show less



Carter-Wallace Inc.

• Administrator, R&D Documentation

  • Mar 1987 - Aug 1998

  Responsible for controlling the maintenance and distribution of records that represent R & D interaction with regulatory agencies. Managed documentation for the conduct of clinical studies. Performed liaison functions for foreign and domestic licensors. Managed a group of Documentation Specialists in the receipt, optical imaging, filing and distribution of all R & D external and internal documentation. Responsible for controlling the maintenance and distribution of records that represent R & D interaction with regulatory agencies. Managed documentation for the conduct of clinical studies. Performed liaison functions for foreign and domestic licensors. Managed a group of Documentation Specialists in the receipt, optical imaging, filing and distribution of all R & D external and internal documentation.