Manager Study Design and Programming

Job Overview:Serve as the technical leader. Supervise, mentor and evaluate performance of technical services staff and leadership in various locations and aide in staff development, career development, interpersonal skills, and achievement of competency standards. Assist in the development and implementation of solutions to global technical service issues and concerns regarding database activities, including proactive prevention strategies based on metrics and forecasts. Support Data Management service budgets by providing forecasts of technical services staff based on contracted services. Provide expertise and advice to Data Management to produce quality clinical data. Support technical services staff in achieving internal and external client satisfaction through delivery of quality deliverables, on-time and on-budget. Receive client satisfaction surveys and implement appropriate action plans as necessary. Assist in development of global technical services competency models and assist with the development of training programs to ensure staff achievement of position competencies. Participate in the development of global, harmonized SOPs and specific quality work instruction for study design group activities. Maintain budget for technical service staff activities that contribute to data management objectives. Maintain productivity and quality indicators for the clinical application programmers. Assist in the process of the Inter-Company Agreements and collaborate with Business Development and Finance to standardize guidelines, process, and costs for proposals contracts. Manage utilization and billability of technical service staff, planning for resource allocation / recruitment based on forecasts, metrics, individual skills, competencies, and availability. Assist with revenue and operating margin performance of the global data management group to agreed targets. Maintain technical competency through participation in internal and external professional seminars. Provide advice and support to business development for time and cost estimates and prepare and present to potential clients on global technical support capabilities. Assist with business development and marketing activities at client presentations and professional seminars. Create strategy and ensure participation of technical services staff in professional organizations such as Oracle User Group or Medidata User Group. Ensure all staff activities are completed according to Covance SOPs, Work Instructions and project specific guidelines and are in accordance with Good Clinical Practice. Conduct technical planning for multi-protocol projects. Ensure review of draft and final annotated data capture instruments and Physical Data Models for projects to ensure quality and consistency. Ensure quality control procedures are followed for database development. Ensure the filing of study documentation is maintained to the standard required according to processes and acceptable for audit. Initiate and participate in the ongoing review of the processes used by the Technical Services Group to ensure adaptation of best practices. Interact with the management and wider team in related disciplines, e.g., Clinical Data Management, Biometrics and Global Applications, to ensure consistency in approach, ongoing co-operation and teamwork and regular discussion regarding process improvements. Track project milestones and budget usage for the database programming and study build tasks. Communicate on a global level and encourage teamwork on a global basis. Work on complex problems where analysis of situations or data requires an evaluation of intangible variables; development of technical solutions to abstract problems which require the use of ingenuity and creativity. Demonstrate excellent problem solving skills, a proactive approach and a willingness to make decisions on a regular basis and communicate these clearly. Take an overview of difficult projects, providing ongoing supervision, advice and consultation to the SDP Group for Oracle InForm or Medidata RAVE to ensure timely and efficient completion of these projects. Ensure all issues raised are addressed and all potential issues are handled proactively. Assist with ongoing financial review of projects to ensure that all issues and highlighted and resolved as quickly as possible and all non-contract tasks are identified, tracked and included in change order forms. Work with training specialists and other disciplines to ensure project and line teams are receiving training required fulfilling current role or development. Provide ongoing technical training and mentoring for the staff to ensure thorough knowledge of the processes used and the ongoing technical development. Prioritize personal workload and that of the team to meet specified completion dates and perform work without direction. Ensure good communication across the global management team.

Work closely with the Human Resources team to devise recruitment strategies to maximize our ability to find and recruit high caliber staff. Perform interview utilizing DDI selection process. Education/Qualifications:University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology). Broad knowledge of drug development process. Knowledge of budgets and relationship to productivity targets. Thorough knowledge of the EDC Data Management Systems to ensure the efficient integration and adaptation. Basic knowledge of SQL and relational databases. Working knowledge of medical coding dictionaries and their application. Knowledge of resource management systems / processes. Working knowledge of time and cost estimate development and pricing strategies.

Working knowledge of System Validation Life Cycle in relationship to the implementation of new applications. Experience:Minimum nine & half (9.5) years of relevant work experience with approximately three (3) or more years supervisory experience to include data management, database and dictionary support activities. Demonstrated skill for management of staff exceeding 5 employees within one region. Excellent oral and written communication and presentation skills. Knowledge of clinical trial process and data management, biometrics, and systems applications to support operations. Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies. Demonstrated ability to lead multidiscipline teams, on achievement of department goals, objectives, and initiatives. Demonstrated ability to handle multiple competing priorities. Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system. Demonstrated ability to establish teams that collaborate on issues as they arise and ensure that solutions are communicated to all affected staff on a global basis. Proven managerial and interpersonal skills.