Data Management Quality Lead

Responsibilities: Excellent employment opportunity for a Data Management Quality Lead in the Gaithersburg, MD area. Provide oversight and advice to the clinical project team(s) regarding the DM activities and deliverables Manage and resolve issues related to DM deliverables by developing solutions to complex problems to ensure consistency across organization Provide input to the DM related activities associated with regulatory inspections/audits Provide DM business expertise and consultancy in the selection and use of software systems and vendors Oversee quality and consistency with company strategies and standards across therapeutic areas Work with the Standards Group to provide input into clinical project standards and processes based on industry best practices Facilitate and manage valid change requests of project standards to the Standards Committee Assess company CRDM needs and areas of improvement and recommends changes to the operating model Management and oversight of vendor performance. Review, assess and manage DM delivery against KPIs and overall DM performance Provide input into the contract process for the CRDM vendor Manage all DM timelines and DM Deliverables for assigned studies Ensure DM billing is accurate and forwards recommendation to CDM for payment of invoices. Accountable for the execution and overall quality of DM activities and deliverables. Act as the single point of contact for all data management deliverables for the study team during the study set-up phase, responsible for the CRF design, DB specifications (including edit checks, CRF working instructions, etc.), during study conduct, and study close-out activities. Provide guidance and supervision to Lead Data Managers/DM Team Leads working on the study (CRO or in-house) Accountable for "real time" Data Management, ensuring that DM conducts initial reviews within 5 calendar days of a patient's data entering the EDC system, and manages the average query aging to no more than 30 calendar days. Experience: Minimum of a BS in life sciences or computer science degree Strong Data Management experience in the Biotech/Pharma/CRO industry (at least 5 years) Strong Oncology Therapeutic Expertise (at least 3 years) Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) Experience of clinical databases, different clinical data management systems and electronic data capture (EDC) Demonstrate understanding and experience in query management process and reconciliation activities Excellent written and verbal communication skills Fladger Associates