PROGRAM MGR, CLINICAL EVENTS
PROGRAM MGR, CLINICAL EVENTS
DCRI - Clinical Events Commitee
The Program Manager, independently oversees data management and technical components for Clinical Event Coordination (CEC) and Safety Surveillance and serves as a leadership resource in the day-to-day data management operations. The Program Manager ensures that projects are completed in accordance with current standards, meet sponsor and regulatory specifications. This position also ensures appropriate use of project management and data management tools and serves as a resource to data managers in troubleshooting project-related issues. The Program Manager supports CEC/SS teams, coordinating several or large projects, and may perform clinical data specialist (CDS) responsibilities on a project, as needed.
The Program Manager, Clinical Events Classification-Safety Surveillance, is responsible for and provides oversight and management for technical aspects of projects in CEC-SS. The Program Manager oversees and mentors assigned Clinical Data Specialist (CDS) to ensure that contracted technical services are performed on schedule, within budget, and in accordance with sponsor specifications. The individual facilitates problem resolution and issue escalation across projects or programs. The Program Manager reports to the Assistant Director and works closely to align new processes and procedures.
Budget/Scope of Work
Provides direction and input in the development of operational plans for technical aspects of new project proposals, as well as potential collaborations.
Analyzes and proposes best practices for implementing and conducting technical project activities for CEC and Safety Surveillance
Provides estimates for data management scope changes to the Project
Oversees forecasting and resourcing for project technical areas.
Facilitates problem-resolution and issue escalation across projects or programs.
Supports management of internal and external customer expectations.
Oversees timelines of the technical aspects of a project
Serves as primary liaison with Data Solutions and Technical Services on technical timelines and deliverables
Prepares for and hosts external audits (sponsor or FDA); approves corrective action plan.
Oversees development of data management components of project plans, such as integration of multiple data sources or migration of data between systems. Reviews and provides guidance on project documentation to ensure compliance with SOPs
Participates in business development activities such as presentations to prospective sponsors, development of scope of work, and cost estimates for technical areas.
Maintains a working knowledge of CEC, safety surveillance, healthcare and research standards; provides leadership in choosing best practices for data management processes, including data
Maintains a working knowledge of clinical data management systems. Presents information from external training sessions and conferences. Serves as 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.
Oversees departmental training and development of infrastructure, including identifying training needs in order to ensure that training reflects DCRI, Data and industry standards. Conducts training sessions for employees on a regular basis.
Provides 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 projects, Educates internal and external partners on the technical components of CEC and Safety Surveillance. Obtains and analyzes user needs for business processes. Provides input for creation and maintenance of department work processes. Identifies process trends across trials, underlying root causes and improvements for efficiency.
Manages technical activities and staff in the department. Executes department strategic planning efforts and communications; may participate in development. Plans, coordinates, and allocates technical resources across the department. Participates in and facilitates data management and organizational improvement initiatives. Serves as a mentor to direct reports by helping select appropriate training, assignment of trials, and responsibilities that facilitate career progression. Coaches for successful completion of new tasks. Screens, interviews and participates in hiring decisions 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. Manages performance issues, including documentation of Disciplinary Action & Performance Improvement Plan.
Certified Clinical Data Manager (CCDM) designation is highly preferred.
2021 PROGRAM MGR, CLINICAL DATA MGMT
Job Family Level
Full Time / Part Time
Regular / Temporary
Requires a Bachelors degree in Life Science or Biological Science;Masters degree preferred.
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 is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion,sexual orientation, or veteran status.
Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.