Eileen McNulty

Responsible for all project team leadership and Site/CRO management for Global studies (Phase I-IV) including: Selection of CRO Protocol, case report form and informed consent development Training of CRAs and site personnel on protocol and CRF completion Responsible for building and maintaining positive client relationships Preparing and reviewing data for data and safety monitoring board Protocol and CRF review for consistency Line Listing Reviews Adverse event reconciliation Review of Trial Master File Review of external data contracts (CROs, sites, core lab vendors and radiology vendors) Responsible for meeting all project budgets and timelines Interact and communicate with KOL’s, Study Investigators and site personnel Plan and Present at Investigator meetings Experience with CTMS Knowledge of GCP/ICH guidelines Therapeutic experience includes: Oncology, Cardiology, Infectious Disease, Rheumatology

Responsible for review of all primary and secondary efficacy data for oncology and lupus studies. Work with Clinical Operations and Data Management to ensure quality data from the sites. Work with biostatisticians and programmers to develop programs to streamline clinical review of large data bases. Work with the study team to develop case report forms and data management plans for oncology studies and lupus studies. Provide training to site personnel and global CRO’s on expectation of CRF completion and protocol adherence. Extensive experience with electronic data capture and developing edit specifications for databases. Provided support for the application of new lupus drug to the FDA for approval. Responsible for training and managing of new employees. Interact with and communicate with Investigators and Key Opinion Leaders (KOL). Knowledge of GCP/ICH guidelines

Provide high quality clinical monitoring support for pharmaceutical, biotech and device companies on a contract basis. Extensive experience with monitoring, electronic data capture, site selection, site initiation, protocol development, case report form development and review, clinical review and query management. Responsible for training and managing of new employees. Experience monitoring all phases of research and working with global CROs. Interaction/Communications with Investigators and Key Opinion Leaders (KOL). Knowledge of GCP/ICH guidelines. Fully equipped home office

In this position I was the manager and designer of educational programs aimed at the scientific community. Specific responsibilities include: planning symposia, faculty updates, advisor board meetings and other special projects; working closely with marketing managers and sales force to develop marketing plans for products; meeting and selecting vendors to assist with projects, controlling expenses and staying within budget.

In this position I managed the day to day management of a 3,618 patient mortality trial in the therapeutic area of cardiovascular disease. Specific responsibilities include: designing the protocol and amendments, designing case report forms, interviewing and hiring appropriate consultants, site selection, planning regional coordinator meetings, training coordinators to work within protocol specified guidelines, fielding questions from clinical centers on protocol, study drug and clinical issues, follow up on adverse experiences, and train new staff members. I also maintained the study budget and departmental budget. In this position I developed a job description and hired for a new position

Provided high quality monitoring of cardiovascular studies. Experience with all aspects of site management from study initiation to study close out visits. Maintain regulatory binder at sites. Meet with study coordinators and investigators to discuss findings of monitoring visits. Experience with protocol and case report development and review