Manager of Statistical Programming Job in Durham 27713, North Carolina US
Description:
The Manager contributes to and leads strategic initiatives for the structure and development of a Programming team in order to achieve the overall goals and mission of Global Technical Services. The Manager’s primary function is to provide direct project and team oversight. General responsibilities include supervision and management of staff; ensuring staff are adequately trained, mentored, and developed. Be responsible for the execution and productivity of Data Sciences programming activities on individual projects, ensuring adherence to regulatory standards. Provide input to continuous productivity and quality improvement. Ensure proactive planning takes place and provide issue resolution for the team.
- 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
- Manage the annual salary planning for a GTS programming team in line with other GTS Programming managers and directors
- Contribute to and implement a strategy for the structure and development of a GTS programming team
- Resource planning, including monitoring and scheduling the workload of a GTS programming team
- Manage the recruitment process for new GTS team members
- 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
- Attend (as appropriate) client facing meetings to represent GTS on activities including, but not limited to, progress reviews, technical updates on key milestones, bid defenses, client meetings, technical requirements collection, blind data review meetings, population classification meetings
- Represent GTS at internal and external audits and regulatory inspections, as required
- Actively contribute to the proposal and development process.
Experience:
· - Excellent English written and oral communication skills essential
· - Project Management or previous Line Management experience require
· - Experience working with systems used within the Clinical Trial process
· - Experiencing managing a technically focused group within a regulated industry