Associate Director, Clinical Trial Support
Since October 2011
Functional Manager Managing 13 Clinical Trial Associates including Country & Site Start Up Leads and 1-3 Adminstrative Assistants. Responsibilities include: Resourcing, study assignments, interviewing, on-boarding, coaching and problem solving. Recent activities: SOP review, writing new job family including job descriptions
Senior Clinical Study Manager
September 2010 --- October 2011
Managing Clinical Trials Phase II and III Therapeutic areas: Urology, oncology, Pain Successfully lead phase II dose finding study recruiting 1700 subjects 2 months ahead of an ambitions schedule. Managed from start up, 2 outsourced Oncology studies with a transatlantic study team.
Clinical Research Manager
September 2005 --- September 2010
Managed a phase III/IV study with minimum supervision, recruitment completed on time despite a late start outwith my control. Initiated, organized and chaired Monthly Therapeutic Area meetings.
Senior Data Manager
October 2000 --- August 2005
(company formerly known as Yamanouchi) Managed a project, consisting of 3 phase III registration studies, 2 in house and one outsourced. 2 of these studies were the largest in house studies to date. Then successfully managed two large (1000+ subjects) phase III/IV outsourced studies. Acted as back up for Section Head Data Management for planning and resource allocation. Presented at DIA congress.
Senior Study Coordinator
January 1997 --- January 2000
Central Laboratory for Clinical Trial work Also known as Analytico Medinet, now Eurofins. Managed multiple clinical trials according to clinical protocol. Wrote study documents, managed kit production and shipping, presented to Investigator and Monitor meetings. As team leader supervised and coached 3 junior colleagues. Acted as project manager for largest client.
Clinical Data Manager (DM)
January 1995 --- January 1997
CRO serving the Pharmaceutical Industry. Dublin.
AdaptabilityApproachabilityAttention to detailCollaborationCoordinationCreative thinkingEfficiencyIndependenceProblem solvingResponsibilityResult OrientedService oriented
Budget ManagementClinical Data ManagementClinical DevelopmentClinical operationsClinical researchClinical trial budgetingClinical trial managementClinical Trial Management System (CTMS)CoachingCRFCTMSCross-functional team leadershipGood Clinical Practice (GCP)Knowledge of the drug development processLeadershipLife Sciencespeople managementTeam ManagementUrology
Skills and Expertise
Coach and provide guidance to clinical staff.Coach clinical staffCollaborate with project teamCreates a collaborative team environment
Assign activitiesCalculate timelines for conducting and completing the trialCommunicationConduct studiesCoach staffCreate SOPsEnsure good clinical practice (GCP)Lead teamsManage complexityPeople managementWork cross-functionally
MSc (Res) in Lung Fibrosis from University College Dublin in 1995
BSc Hons in Microbiology from National University of Ireland, Galway in 1991
DipEd in Primary Education from Moray House College of Education in 1978