Senior Manager Of Clinical Development

CPL

Dublin City Centre

Senior Manager of Clinical Development and Operations My client is a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercialising differentiated products that address unmet medical needs and in conjunction with the CPL Group are looking to recruit for a Senior Manager of Clinical Development and Operations for their Dublin City Centre offices. The company markets a portfolio of medicines through its orphan, primary care and rheumatology business units. There global headquarters are in Dublin, Ireland. The company also has offices in the US and Europe. The Position The primary responsibility of the Senior Study Manager is to manage the day-to-day operational activities that support Horizon sponsored clinical trials. The primary focus will be on meeting or exceeding the study–specific clinical development plan (CDP) metrics. Responsibilities. Facilitates and accelerates the designing, planning, developing and monitoring of clinical trial(s) according to FDA and ICH guidelines that meet or exceed the CDP. Forecasts and manages study-related finances within established budget parameters and communicates project status to clinical team. Manage and track study-related activities, including: set up and management of Trial Master File (TMF) and/or electronic TMF (eTMF), investigational product/laboratory kit shipments, site-monitoring visit reports review/approval, vendor agreement review/ approval and study-specific plan/guideline development. Manage Contract Research Organization (CRO)/ independent contractors and facilitate communication. Assist in the selection of trial sites and investigators and with the negotiation/execution of site budgets and clinical trial agreements (CTAs. Track vendor contracts/payments. Identify and mitigate study-related issues in a timely and efficient manner. Tracks timely resolution of deficiencies identified in audit report. Perform periodic review of TMF/eTMF to ensure accuracy and completeness. Assist with archive TMF/eTMF following study closeout. Plan, coordinate and prepare for internal/external presentations, visual aids, slides, posters, and attend external meetings for projects. Qualifications and Skills Required: Science degree in related field, scientific background. 7+ years’ experience in pharmaceutical clinical research including organizing and coordinating clinical trials. Thorough knowledge of Food and Drug Administration (FDA) ICH/GCP and European regulations. Strong analytical skills. Excellent written and verbal communication skills. Ability to quickly adapt to new technologies. Ability to travel, including overnight travel, for business-related activities (e.g. CRO Training, Investigator meeting. Suitable applicants should email their cv to aileen.cahill@cpl.ie or call me on 01646007 for a confidential conversation today. This job originally appeared on RecruitIreland.com.

2404 days ago