Ann Mccabe Email & Phone Number

Basking Ridge, Nj

Bridgewater, Nj

Support the Global Clinical Affairs Organization in creating and implementing clinical quality plans to support regulatory and/or market access submissions. Creation and implementation of Clinical Operations LifeCell Operating Procedures (LOPs). Project lead for the Global alignment of LOPs project. Creation and maintenance of training curricula. LOP maintenance including gap assessments against regulations, lessons learned from inspections and annual reviews. Quality control of critical… Show more Support the Global Clinical Affairs Organization in creating and implementing clinical quality plans to support regulatory and/or market access submissions. Creation and implementation of Clinical Operations LifeCell Operating Procedures (LOPs). Project lead for the Global alignment of LOPs project. Creation and maintenance of training curricula. LOP maintenance including gap assessments against regulations, lessons learned from inspections and annual reviews. Quality control of critical clinical study documents and subsequent revisions for each study. Trial Master File Oversight. Audit preparation and inspection readiness. Assist in the creation and revisions of Vendor Management Plans and closure of corrective and preventive action plans. Show less

Independent consultant to the pharmaceutical/biotech/medical device industry with over 20 years experience. Consulted with Pharmaceutical/Biotech/Device companies in a variety of capacities including: Creating and Implementing SOPs; Training Needs Assessments; Training Strategy and Implementation; GCP Presentations; CRO Oversight activities; Quality initiatives: Audit preparation and inspection readiness.

Santa Barbara, California Area

Provided direction on creating and implementing controlled procedural documents. Created and implemented the process for Management of Controlled Procedural Documents. Revised Global SOPs for compliance with ISO 14155:2011. Created presentations for SOP updates as part of the training strategy for SOP implementation. Collaborated with cross-functional teams to develop process improvements. Worked with Clinical Monitoring to develop the monitoring oversight plan and oversight reports. Liaison… Show more Provided direction on creating and implementing controlled procedural documents. Created and implemented the process for Management of Controlled Procedural Documents. Revised Global SOPs for compliance with ISO 14155:2011. Created presentations for SOP updates as part of the training strategy for SOP implementation. Collaborated with cross-functional teams to develop process improvements. Worked with Clinical Monitoring to develop the monitoring oversight plan and oversight reports. Liaison with the clinical teams on quality initiatives: Audit preparation and inspection readiness. Project management of quality projects. Show less

Rockville, Md

Created and implemented learning and development strategy to train OAPI/OPDC staff with the knowledge and skills required to successfully meet business process objectives. Assured the company’s Business Process compliance documents reflected regulated processes and current business operations. Assessed requirements across all therapeutic areas, with respect to GCP, SOPs, and on-boarding programs. Interacted with all levels of employees to assure that training needs were identified and… Show more Created and implemented learning and development strategy to train OAPI/OPDC staff with the knowledge and skills required to successfully meet business process objectives. Assured the company’s Business Process compliance documents reflected regulated processes and current business operations. Assessed requirements across all therapeutic areas, with respect to GCP, SOPs, and on-boarding programs. Interacted with all levels of employees to assure that training needs were identified and successfully addressed on an ongoing basis. Managed both internal and external resources, and alternative approaches such as e-learning and webinar programs to address the key training and development needs on an ongoing basis. Participated in FDA and EMEA inspections. Worked with Quality Management to implement CAPA plans. Show less

Gaithersburg, Md

Provided technical, organizational and leadership on oversight of design and development of Medical Organization’s (MO) training programs. In collaboration with functional area heads, defined training curricula for all MO personnel; ensured availability of learning opportunities on systems and processes to increase efficiency, industry knowledge and compliance; and maintained training documentation in audit-ready condition.

Rockville, Md

Provided OMRI Clinical Research and Development employees with focused cross-functional training. Assessed the needs of the organization and provided new hire orientation, SOP, ICH/GCP and various cross-functional training offerings to all departments. Established, maintained and monitored a system for SOP testing. Implemented an eLearning initiative for detailed training on procedures. Participated in various corporate initiatives: Policies and Procedures review committee, process mapping… Show more Provided OMRI Clinical Research and Development employees with focused cross-functional training. Assessed the needs of the organization and provided new hire orientation, SOP, ICH/GCP and various cross-functional training offerings to all departments. Established, maintained and monitored a system for SOP testing. Implemented an eLearning initiative for detailed training on procedures. Participated in various corporate initiatives: Policies and Procedures review committee, process mapping task force, SOP committee and IMPACT (clinical trial management software) implementation. Facilitated cross functional groups in the creation of OMRI processes. Show less

Media, Pa

Managed the Clinical Research training program at a major pharmaceutical company. Assessed the training needs across clinical, data management, statistics, programming and the medical documentation center to create a training plan. Created in-house training programs, new employee clinical orientation program, and core competency assessments. Coordinated and assessed external offerings. Maintained a training database and records for all R&D employees. Developed and presented a training… Show more Managed the Clinical Research training program at a major pharmaceutical company. Assessed the training needs across clinical, data management, statistics, programming and the medical documentation center to create a training plan. Created in-house training programs, new employee clinical orientation program, and core competency assessments. Coordinated and assessed external offerings. Maintained a training database and records for all R&D employees. Developed and presented a training program, “The Clinical Data Management Highway” for a client’s data management department. Developed the process for creation of clinical development plans. Organized and conducted a study in “Best Practices in Monitoring”. Interviewed international team members and presented findings in a report. Developed materials for SOP training sessions, creating slides, facilitator’s guides and games for review of the materials. Taught monitoring and data management continuing education classes at Villanova and Georgetown Universities. Show less