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Manager, Clinical Database Programming
-Provides a broad range of leadership and team building capabilities to manage the performance and development of a clinical programming team in order to achieve departmental goals and objectives.
-Conduct performance appraisals.
-Evaluate and resolve complex personnel issues.
-Implement disciplinary procedures if required.
-Provide support to project leads to help manage changes in scope and contractual issues.
-Proactively participate in and/or lead process/quality improvement initiatives.
-Communicate with other operational groups regarding workflow, process, timelines, and resource planning to ensure transparency between all functions as well as any external support groups.
-Provide technical leadership, and project management for required technical aspects supporting clinical trial activities.
-Responsible for managing technical activities either Clinical Systems and Support Programming and/or Database Programming and/or Statistical Programming, including but not limited to CTMS Set-up, PMED Set-up, Database Set-up, Consistency checks, import and export programming, analysis dataset and table, figure and listing programming and any ad-hoc programming required to support a clinical trial process.
-Identify and adequately resolve operational and technical problems.
-Work closely with the Quality, Process and Training Groups to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations.
-Assist in defining gaps in process, developing, and deploying appropriate operating procedures.
-Lead cross functional meetings and drive initiatives to ensure the delivery of milestones and timelines for clinical trials.
-Provide relevant technical training and/or mentoring for staff to assist them in resolution of problems encountered in the conduct of their daily work.
-Actively contribute to the proposal and development process.
-Demonstrate excellent knowledge of the processes required to operate a clinical trial and the best practice used at every stage of the trial.
-Flexibility and ability to handle multiple responsibilities, over a global footprint and ability to manage across divisions, departments and cultures.
-Ability to create, maintain and define strategies to improve the efficiency for the running of a clinical trial.
-Strategic awareness of our business environment, including application of CRS concepts in order to achieve best practice and promote continuous improvement.
-Demonstrated ability to learn new systems and function in an evolving technical environment.
-Awareness of CRS software and tools, and ability to evaluate innovations.
-Strong project management and leadership ability.
-Ability and willingness to make business decisions.
-Effective communication skills that include provision of accurate information to stakeholders, proficient in English, strong written and oral communication skills, ability to work effectively with and motivate virtual teams. In addition, possess a strong cultural awareness.
-Personal skills include ability to manage competing priorities, function independently, attention to detail, excellent organizational and project management skills, flexibility to change and fulfilling activities to completion.
-Demonstrated skills of working effectively in a quality-focused environment, and commitment to refine quality processes.
-Advanced people management and leadership skills Business/Operational skills that include customer focus (internal and external), commitment to quality management and problem solving.
-Influencing skills including negotiation, problem solving and teamwork.
-Ability to negotiate with respect and influence to achieve results.
-Proven ability to work as a team player and ability to multi-task.
-Tenacity to work in an innovative environment.
-Project Management or previous Line Management experience required
-Experience working with systems used within the Clinical Trial process
-Experiencing managing a technically focused group within a regulated industry
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