JOB SUMMARY
This position is responsible for overseeing the delivery of Data Operations Technical Service team at regional level. Plans for the efficient allocations of resources and ensures delivery across all locations is effective, efficient and profitable. Maintain awareness of current developments and changing technology within the industry, recommends strategic technical solutions for business unit in coordination with IT and Data Management department leadership.
This position is responsible for overseeing the delivery of Data Operations Technical Service team at regional level. Plans for the efficient allocations of resources and ensures delivery across all locations is effective, efficient and profitable. Maintain awareness of current developments and changing technology within the industry, recommends strategic technical solutions for business unit in coordination with IT and Data Management department leadership.
JOB RESPONSIBILITIES
• Oversees and manages resource management and maintains utilization/realization at regional level. Ensures that all projects maintain the correct level of gross profit, budgets are maintained and changes in scope applied as necessary within assigned region. Additionally, implements a project review process to ensure that resource, deliverables, scope, quality, and budget are maintained appropriately.
• Contributes to the development of policies, procedures and standards for Data Operations Technical Services activities. Ensures implementation and training of standard operating procedures for staff.
• Serves as primary interface between company and sponsors, vendors and other department in the area of Data Operations Technical Services.
• Regularly reviews all relevant projects for financial control and operational productivity. Provides operational metrics at regional level.
• Supports the achievement of Data Operations departmental sales, revenue, utilization and gross profit targets.
• Ensures compliance with Good Clinical Practices sponsor contracts as well as all Food and Drug Administration and International Conference on Harmonization requirements.
• Participates in the sales and marketing function as it relates to operational activities. Provides input and review/approval of study proposals in the scope of Data Operations Technical Services tasks.
• Collaborates with senior management of pharmaceutical and biotechnology sponsors on operational issues and with other vendors as required.
• Ensure implementation of Data Operations Technical Services global strategy at regional level.
• Collaborates with senior management and contributes operational input to other departments as appropriate.
• Leads Data Operations initiatives throughout applicable departments within Biometrics Business Unit.
• Liaises with Human Resources department for execution of recruitment strategies at regional level.
• Serves as a primary source of operational information in the budgeting process for clinical programming, clinical coding and randomization services projects and department.
• Serves as business owner of Data Operations departmental applications.
• Identifies, manages and oversees the business need for the strategic use of technology. Selects and managers vendors and oversees the use of resources.
• Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences.
• May represent the Company at professional meetings or seminars.
• Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
• Oversees and manages resource management and maintains utilization/realization at regional level. Ensures that all projects maintain the correct level of gross profit, budgets are maintained and changes in scope applied as necessary within assigned region. Additionally, implements a project review process to ensure that resource, deliverables, scope, quality, and budget are maintained appropriately.
• Contributes to the development of policies, procedures and standards for Data Operations Technical Services activities. Ensures implementation and training of standard operating procedures for staff.
• Serves as primary interface between company and sponsors, vendors and other department in the area of Data Operations Technical Services.
• Regularly reviews all relevant projects for financial control and operational productivity. Provides operational metrics at regional level.
• Supports the achievement of Data Operations departmental sales, revenue, utilization and gross profit targets.
• Ensures compliance with Good Clinical Practices sponsor contracts as well as all Food and Drug Administration and International Conference on Harmonization requirements.
• Participates in the sales and marketing function as it relates to operational activities. Provides input and review/approval of study proposals in the scope of Data Operations Technical Services tasks.
• Collaborates with senior management of pharmaceutical and biotechnology sponsors on operational issues and with other vendors as required.
• Ensure implementation of Data Operations Technical Services global strategy at regional level.
• Collaborates with senior management and contributes operational input to other departments as appropriate.
• Leads Data Operations initiatives throughout applicable departments within Biometrics Business Unit.
• Liaises with Human Resources department for execution of recruitment strategies at regional level.
• Serves as a primary source of operational information in the budgeting process for clinical programming, clinical coding and randomization services projects and department.
• Serves as business owner of Data Operations departmental applications.
• Identifies, manages and oversees the business need for the strategic use of technology. Selects and managers vendors and oversees the use of resources.
• Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences.
• May represent the Company at professional meetings or seminars.
• Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
Candidate Profile
• Master degree preferred in computer science or related field, and extensive experience, particularly in design, development and implementation of clinical data collection systems targeted at supporting large-scale multiple site clinical trials with supervisory experiences required.
• Experience in a Contract Research Organization or Pharmaceutical/Biotechnology company is a plus.
• Experience working in a matrix structured environment with multiple product lines is essential. In-depth knowledge of relevant regulations and strong understanding and usage of medical terminology.
• Excellent leadership/management skills with ability to handle multiple tasks to meet deadlines in a high stress environment.
• Effective organizational, presentation, documentation, analytical, Project Management and interpersonal skills with demonstrated ability to lead and motivate a matrix team.
• Proficiency in Word, Excel, and PowerPoint.
• Ability to travel as necessary (up to 25%)
• Master degree preferred in computer science or related field, and extensive experience, particularly in design, development and implementation of clinical data collection systems targeted at supporting large-scale multiple site clinical trials with supervisory experiences required.
• Experience in a Contract Research Organization or Pharmaceutical/Biotechnology company is a plus.
• Experience working in a matrix structured environment with multiple product lines is essential. In-depth knowledge of relevant regulations and strong understanding and usage of medical terminology.
• Excellent leadership/management skills with ability to handle multiple tasks to meet deadlines in a high stress environment.
• Effective organizational, presentation, documentation, analytical, Project Management and interpersonal skills with demonstrated ability to lead and motivate a matrix team.
• Proficiency in Word, Excel, and PowerPoint.
• Ability to travel as necessary (up to 25%)
Additional Information
Qualification : Master degree
Experience : 5+ years
Location : Gurgaon/Hyderabad
Industry Type : Pharma
Functional Area : Clinical Programming
End Date : 30th April, 2019
Qualification : Master degree
Experience : 5+ years
Location : Gurgaon/Hyderabad
Industry Type : Pharma
Functional Area : Clinical Programming
End Date : 30th April, 2019
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