Data Management Lead I (FSP) - UK, Ireland, Romania, Hungary

The role can be based in UK, Ireland, Romania, Hungary.

The Data Management Lead (FSP) provides leadership and expertise in all aspects of Data Management and Clinical Data and Database Programming. The Data Management Lead manages the delivery of all relevant data operations activities from database setup through database lock and data transfers.

General areas of responsibility include: coordination of the relevant Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders (clinical, biostatistics, medical, medical writing etc.) and the client as a single point of contact to ensure that the contracted data deliverables are being met – specifically in terms of timeliness, financial management and quality.

May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned.

Main responsiblities: Providing Data Management leadership across assigned trial(s) acting as the Trial Data Manager where needed. Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes. Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards. Performs Data Management activities for start up of a study including preparing the eCRF, CCG’s where needed. Data Handling plan (DHP), Data Review Plan (DRP) and performing user acceptance testing (UAT). Manage local lab set up for the Clinical Database as applicable. Performs Data Management hands on activities during the study. Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM). Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation. Supports and assists Junior staff for assigned trial. Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner. Provides effective input into DM initiatives and innovations for quality, efficiency, and continuous improvement in scientific and operational excellence. Tracks and reports status and progress for assigned trials, indications, or programs. Ensures adherence to GCP, Data Management standards, SOPs/WPS and process guidelines .QualificationsIdeal candidate will possess: University or college degree in life science, computer science, pharmacy, nursing, or equivalent relevant degree. Fluent English (oral and written). Ability to work under pressure demonstrating agility through effective and innovative team leadership. Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders. Excellent problem-solving skills. Ideally 4 years’ experience in Drug Development with at least 3 years' in Clinical Data Management. Excellent verbal and written skills.