PROGRAM MGR, CLINICAL DATA MGMT
Duke University and Duke University Health System - Durham, NC

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Occupational Summary
The Program Manager, Clinical Data Management independently oversees data management operations for an assigned therapeutic area or program and serves as a leadership resource in the day-to-day data management operations for that program area.Ensures that projects are completed in accordance with the applicable regulatory requirements as well as the established budget, timelines, and sponsor specifications. Ensure appropriate use of project management and data management tools. Serve as a resource to data managers in troubleshooting project-related issues. Is a manager supporting Clinical Data Management (CDM) teams, coordinating several or large projects and reports to Assistant Director, CDM.

Work Performed
PROJECT MANAGEMENT
The Program Manager is responsible for and provides technical and management oversight for the projects. The Program Manager will oversee project management through supervision and mentoring of assigned data management staff to ensure that contracted services are
performed on schedule,within budget, in compliance with applicable regulatory requirements, and in accordance with sponsor specifications. Facilitates problem-resolution and issues escalation across therapeutic area projects or program.
In addition:

# Maintains a working knowledge of healthcare and research standards; provides leadership in choosing best practices for data management processes, including Data Management models.
# May participate in business development activities such as presentations to prospective sponsors, development of scope of work and cost estimates across multiple therapeutic areas
# Facilitates problem-resolution and issue escalation across therapeutic area projects or program
# Participates in review and provides input in writing proposals and grant applications
# Analyzes and proposes best practices for implementingand conducting project activities
# Develops complex project plans, such as integration of multiple data sources or migration of data between systems
# Educates internal and external partners on EDC and data surveillance activities.
# Serves as a project leader for therapeutic area/program projects as assigned # Provides direction and input in the development of operational plans for new project proposals including the services the DCRI and CDM will provide, as well as potential collaborations and outsourcing
# Prepares for and hosts external audits (sponsor or FDA)
# Manages internal and external customer expectations
# Oversees budgets of projects in their therapeutic areas and implements corrective action to maintain budget
# Oversees forecasting and resourcing for program area
# Performs clinical data specialist role as needed

TECHNICAL
The Program Manager performs technical and business analyst activities for developing new data management platforms and modules to be used within CDM and across therapeutic areas.

# Provides the expertise and leadership for defining data management project requirements, considerations and effective implementation options utilizing novel or complex data systems and coordination of appropriate resources
# Oversees design and implementation of appropriate data integration plan for complex projects, including management of vendors
# Obtains and analyzes user needs for business processes
# Provides input for creation and maintenance of department work processes
# Identifies process trends across trials, underlying rootcauses and improvements for efficiency
# Performs clinical data specialist role as needed
# May perform project leader role on data or stats only projects

TRAINING
The Program Manager, Data Management maintains skills at the Manager, Clinical Data Operations level.

The Program Manager, Data Management will:

# Serve as a mentor to direct reports by assisting with selecting and scheduling appropriate training, assignment of trials and trial responsibilities that
facilitate career progression and coaching for successful completion of new tasks.
# Present information from external training sessions and conferences.
# Conduct training sessions for employees on a regular basis.
# Manage and provide publicly available external training courses or certification programs.
# Oversee of department trainingand development infrastructure including identification of training needs - ensure that training reflects DCRI, CDM and industry standards.
# Maintain working knowledge of clinical data management systems.

ADMINISTRATIVE/SUPERVISORY MANAGEMENT
The Program Manager position is a fully functioning manager of staff with full authority for candidate selection, orientation, coaching, performance management and, when necessary, disciplinary action including termination.
# Responsible for the screening, interviewing and hiring of team members
# Assures department orientation and training, effectively communicates and sets expectations and assures that staff is qualified by education, training and experience to perform their jobs
# Serves as a mentor to direct reports by assisting with selecting appropriate training, assignment of trials & responsibilities that facilitate career progression
# Coaching for successful completion of new tasks
# Conduct annual and interim individual performance reviews, set performance goals, provide feedback and coach staff
# Manages Clinical Data Management activities and staff across a therapeutic area and/or functional sub-groups
# Executes department strategic planning efforts and communications; may participate in development
# Manages performance issues, including documentation of Disciplinary Action & Performance Improvement Plans
# Plans, coordinates, and allocates resources across multiple trials within their group
# Participatesin and facilitates data management and organizational improvement initiatives

Minimum Qualifications
Education

Requires a Bachelors degree in Life Science or Biological Science; Masters degree preferred. Experience

6 years directly related data management experience to include at least 2 years of administrative, supervisory or project management experience. Experience managing multiple projects & teams and experience supervising staff, particularly departmental teams or sub-groups are highly valued. Certified Clinical Data Manager (CCDM) designation is strongly recommended. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Duke University and Duke University Health System - 18 months ago - save job - - block
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