Summary:
The Manager, Data Management (DM) will serve as a key member of the Data Management Leadership Team, supporting the strategic direction for the data management discipline, and ensuring that appropriate techniques are used which guarantee the validity, accuracy, and overall quality of clinical trial data. The Manager, DM will lead all data management and clinical coding activities, as well as contribute to process improvement activities and positive customer experiences. They are also responsible for CDM project timelines and financial results.
Responsibilities:
- Develops and implements resourcing strategies to ensure all CDM projects are completed in a high-quality manner, on time, and within budget. This includes evaluating the quality and competency of all CDM resources that are to be used on projects.
- Provides strategic leadership to develop and implement CDM processes and ensure that processes and systems are aligned with corporate strategy and objectives.
- Identifies CDM activities outside the scope of contracted work, prepares cost analysis documentation and follows scope issues through to resolution.
- Represents data management on project teams. May serve as Lead DM on projects, as needed.
- Manages scheduling and time constraints across multiple projects and multiple locations.
- Keeps sponsor and team members aware of project issues.
- Tracks timelines in relation to work completed and keeps CDM management, sponsor and the project team appraised of progress towards milestones.
- Maintains a consistent, manageable workflow for CDM project team by monitoring enrolment information and communicating with project team to actively influence data collection.
- Conducts an analysis after study completion to determine positive and negative factors affecting the project and provides this information along with study metrics to CDM management.
- Participates at bid defense meetings and sponsor presentations.
- Accurately estimates hours needed to complete CDM activities and proactively keeps Project Leader and CDM management informed of resource needs and under/over utilization.
- Keep management abreast of issues and progress on all assigned projects.
- Provides or arranges for project specific training for CDM team members.
- Monitors quality of work performed by CDM project team; coaches staff where necessary.
- May act as company lead for client and regulatory audits.
- Approves and tracks PTO requests for direct reports to ensure coverage during peak times.
- Reviews timesheets/expense reports/invoicing for utilization and payment.
- Reviews and approves non-billable travel requests for the data management team.
- Support business development activities, as applicable.
Managerial Requirements/ Responsibilities:
Position will have management responsibilities. Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, coaching/performance management, goal setting, & salary.
Education:
· Bachelor’s degree in related field or equivalent combination of education and experience
Experience:
· Ten plus years of clinical data management experience in pharmaceutical industry and/or clinical research organization.
· Extensive experience as a Lead Data Manager, including oversight responsibilities of team members and project financials.