Lead Programmer Analyst (GCPA)

Job Overview:

Job Location: Bangalore or Mumbai (India)

 Functional leadership with overall global responsibility for delivering technical services (Imaging, EDC Database set-up, data integration and support) to achieve quality on time requirements for data management projects. Assist with and implement global strategies regarding data management database activities to increase productivity, increase financial margins and business market shares. Maintaining optimal department processes and implementing excellent project-specific strategies. Develop and maintain a close liaison with project team members, and Data Managers to drive the technical aspects of project delivery. Serve as the technical leader. 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. 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. 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. Review literature and research technologies/procedures for improving global technical services staff practices. 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. Ensure standardization of OC global library objectives to enhance reusability. 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. 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 9.5 to 12 years of relevant work experience 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.