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Program Manager Clinical Data Management, DCRI

Job description


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Program Manager Clinical Data Management, DCRI
DCRI - CDI

Occupational Summary:
The Program Manager, 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. TheProgram Manager ensures that projects are completed in accordance with the applicable regulatory requirements as well as the established budget, timelines, and sponsor 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 Clinical Data Management (CDM) teams, coordinating several or large projects, and may perform clinical data specialist (CDS) responsibilities on a project, as needed.

Work Performed:
Provides direction and input in the development of operational plans for new project proposals, including services that DCRI and CDM will provide, as well as potential collaborations and outsourcing. Analyzes and proposes best practices for implementing and conducting project activities.
Participates in review, and provides input in writing proposals and grant applications. Provides estimates for data management scope changes to the Project Leader. Oversees forecasting and resourcing for program area. Facilitates problem-resolution and issue escalation across therapeutic area projects or programs. Supports management of internal and external customer expectations. Serves as project leader for therapeutic area/program projects as assigned. Oversees budgets of projects in their therapeutic areas and implements corrective action to maintain budget.
Prepares for and hosts external audits (sponsor or FDA); approves corrective action plan. Stays current with applicable regulations and guidance, and provides and seeks clarification. Develops complex 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. Meetings Participates in business development activities such as presentations to prospective sponsors, development of scope of work, and cost estimates across multiple therapeutic areas. Therapeutic Area Knowledge Maintains a working knowledge of healthcare and research standards; provides leadership in choosing best practices for data management processes, including data management models.
Training
Maintains a working knowledge of clinical data management systems. Manages and provides publicly available external training courses or certification programs. 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, CDM 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 complex projects, including management of vendors.
Production
Educates internaland external partners on EDC and data surveillance activities. 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.
Administrative
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. Plans, coordinates, and allocates resources across multiple trials within their group. 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.

Requisition Number
401310609

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
2021 PROGRAM MGR, CLINICAL DATA MGMT

Job Family Level
76

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

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 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

92868BR

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.

PI101381790

 

 

 

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Job No:
Posted: 2/28/2018
Application Due: 4/29/2018
Work Type:
Salary: