AD, Clinical Data Management

Job Overview Department leadership with the responsibility for ensuring successful delivery of Data Management services to clients and project teams including monitoring compliance and performance while maintaining quality. Responsibility for all aspects of the administration, management, and organization of the department and has overall responsibility for the professional and personal development for individuals within Data Management. Summary of Responsibilities Ensure that the work carried out in the Data Management department is in strict accordance with relevant protocols, Standard Operating Procedures and Good Clinical Practice and that the quality of all services meets or exceeds customer requirements. Collaborate with peers to develop and/or implement global harmonized SOPs and specific quality processes and procedures for Data Management activities. Responsible for managing the Data Management department including managing performance and career development via the PMD process, regular catchups and status meetings and ensuring that all group members are aware of objectives and job responsibilities. Ensure attention is also paid to interpersonal skills and achievement of competency standards. Review any individual issues with managers and staff proactively and in a timely fashion, work with the supervisors to resolve all issues in a supportive manner, creating and maintaining performance plans, as appropriate. Provide constructive feedback as appropriate. Collaborate with peers to establish global Data Management competency models and assist with the development of training programs and ensure staff achievement of position competencies. Provide leadership guidance and support to Data Managers to ensure that studies are delivered according to Sponsor requirements on time, to high quality and within budget. Manage all project team members effectively providing training, acting as source of advice and performing oversight as appropriate. Overall responsibility for departmental recruitment and hiring decisions. Determine required staffing levels to meet short-term and long-term department needs, liaising with senior management as appropriate. Ensure that all new hires are assigned objectives and receive applicable training. Develop and approve departmental strategies and objectives that align with company-wide goals and targets. Review and approve department metrics for input into financial costing models. Ensure that these are kept up to date and that Business Development is aware of any updates. Provide financial oversight to drive profitability and ensure departmental financial targets and business requirements including expected margins are met. Establish global Data Management processes and implement process improvements to increase efficiency and to ensure standards are applied consistently. Provide input into new tools and technologies and make informed decisions regarding which new systems are to be implemented, liaising with technical leaders as appropriate. Actively participate in business development activities including Bid Defenses, Request for Proposals (RFPs) and Request for Information (RFIs). Work closely with our Business Development representatives in maximizing new or existing business opportunities. Act as an advisor to other departments and functions regarding data management activities as appropriate. Establish and maintain strategic client relationships, managing issues and escalation efficiently and effectively, and implement appropriate action plans to address client feedback (i.e., customer survey results) as necessary. Manage and participate in client, internal or agency audits and inspections. May include leading or participating in root cause analyses and tracking and monitoring corrective and preventive actions (CAPA). Implement and monitor client or partnership level Key Performance Indicator (KPI) results as an objective measure of performance. All other duties as needed or assigned. People Responsibilities 1-6 Direct Reports 10–100 Indirect Reports Qualifications (Minimum Required) University/college degree (life sciences, health sciences, information technology or related subjects preferred). Experience and/or education plus relevant work experience, equating to a Bachelor’s degree will be accepted in lieu of a bachelor’s degree. Experience (Minimum Required) A minimum of 10 years related clinical trial experience. Strong people management skills and supervisory skills gained from a minimum of 6 years’ line management experience. #J-18808-Ljbffr Planet Pharma