oracle
Manager Data Management
Acrostar Site Management Co., Ltd.
USA
Onsite
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The Manager Data Management will have responsibility for Data Management staff as assigned and ensures that line reports conduct clinical trials according to all applicable Good Clinical Practice (GCP), Regulatory Requirements, Standard Operating Procedures (SOPs) and the Project Agreement.
Responsibilities
- Manage a team of professional Data Management staff (after 12 months).
- Define and prioritize resource requirements and manage resource assignments across projects.
- Actively contribute to recruitment of new staff.
- Review and prioritise designated resourcing allocation, not only direct line reports, on projects, liaising with Line Manager and Biometrics staff as required.
- Ensure on-boarding, training and integration of all new line reports and that process is completed as per company policy. Ensure that they understand the company policies and procedures appropriate to their position.
- Meet regularly with line reports. Review and manage their workload, welfare and developmental needs.
- Performance management of line reports; set and agree written goals and objectives, competency assessments, coordinate salary reviews and promotions and maintain succession plans.
- Review and approve leave requests, timesheets etc. in line with company policies.
- Provide expert review and guidance for production of Data Management deliverables to internal and external customers.
- Provide technical advice and solutions to internal and external customers to solve problems and improve efficiency.
- Participate in the development and implementation of new processes and technology. This may also include oversight in the development of project specific applications ensuring company documentation and system validation requirements are adhered to.
- Understand scope of work, budget, and scope assumptions.
- Ensure project milestones are met according to agreed timelines and actively manage quality throughout projects.
- Provide support in creation and review of proposals and change orders for the Biometrics Department. This will relate to Data Management, Clinical Programming and Biostatistical activities and will require working with management, project management and business development to gain approval.
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