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PROGRAM MGR, CLINICAL DATA MGMT

Employer
Duke University
Location
Section of Surgical Disciplines Admin

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Administrative Jobs
Technology, Analysts & Programming
Employment Type
Full Time
Institution Type
Four-Year Institution

Job Details

School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary
The Program Manager, Clinical Data Management independently oversee and support data management operations for the Departments of Surgery and Head & Neck Surgery data enterprise to include research, administrative, quality improvement, and health services research projects. Provide leadership, collaboration, and integration of data -related activities across the Department and Health System. Ensures appropriate use of project management and data management tools. Serves as a resource to data managers in troubleshooting project-related issues.

Work Performed
PROJECT MANAGEMENT:

The Program Manager is responsible for and provides technical and management oversight for projects and departmental data portfolio. Manage a team of data, database, and clinical data repository staff. The Program Manager will oversee project management through supervision and mentoring of assigned data management staff to ensure that data is in compliance with applicable regulatory requirements and in accordance with sponsor specifications.

  • Facilitates problem resolution and issues escalation across therapeutic area projects or program. Oversee design and implementation of data integration plans for complex projects; Identify process trends and improvements for efficiency
  • Maintains a working knowledge of healthcare and research standards; provides leadership in choosing best practices for data management processes, including data integration models. May participate in business development activities, development of scope of work and cost estimates across multiple therapeutic areas.
  • Perform technical and business analyst activities for developing new data management platforms; Provide leadership for defining data management project requirements and effective implementation options; Provide support for project management, reporting and analyses, multi-site academic collaborations and data sharing; Initiate and maintain inventory of Department of Surgery databases and establish centralized view of assets and resources; Ensure project completion in accordance with regulatory requirements, established budget, timelines, and sponsor specifications; Participate in project review and provide input inwritten proposals and grant applications with a data component; Identify, submit applications, and obtain external funding for data-related projects; Collaborate with and triage needs to Biostatistics & Bioinformatics, Grants, Clinical Operations, Performance Services, Information Technology, and Data Science teams.
  • Develops complex project plans, such as integration of multiple data sources or migration of data between systems.
  • Educates internal and external partners on Electronic Data Capture (EDC) and data surveillance activities.
  • Provides direction and input in the development of operational plans for new data project proposals.
  • Manages internal and external customer expectations.
  • Oversees budgets of projects in their therapeutic areas and implements corrective action to maintain budget.

TECHNICAL:
The Program Manager performs technical and business analyst activities for developing new data management platforms and modules to be used within clinical departments 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.

  • Provides support for database creation, project management, reporting and analyses, IRB and data agreement, multi-site academic collaborations and data sharing.
  • Identify, submit applications, and obtain external funding for unfunded data projects as opportunities arise.
  • 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 root causes and improvements for efficiency.
  • May perform project leader role on data or stats only projects.

ADMINISTRATIVE/SUPERVISORY MANAGEMENT:
The Program Manager position may be responsible for managing staff with full authority for candidate selection, orientation, coaching, performance management and, when necessary, disciplinary action including termination.

  • Coaches for successful completion of new tasks.
  • Manages 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.
  • Perform other related duties incidental to the work described herein.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Minimum Qualifications
Education

Requires a Bachelor's degree in a related field; Master's degree preferred.

Experience
Six years directly related data management experience to include at least two 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 is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob 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.

Organization

Read our Diversity Profile History

Duke University was created in 1924 by James Buchanan Duke as a memorial to his father, Washington Duke. The Dukes, a Durham family that built a worldwide financial empire in the manufacture of tobacco products and developed electricity production in the Carolinas, long had been interested in Trinity College. Trinity traced its roots to 1838 in nearby Randolph County when local Methodist and Quaker communities opened Union Institute. The school, then named Trinity College, moved to Durham in 1892, where Benjamin Newton Duke served as a primary benefactor and link with the Duke family until his death in 1929. In December 1924, the provisions of indenture by Benjamin’s brother, James B. Duke, created the family philanthropic foundation, The Duke Endowment, which provided for the expansion of Trinity College into Duke University.Duke Campus

As a result of the Duke gift, Trinity underwent both physical and academic expansion. The original Durham campus became known as East Campus when it was rebuilt in stately Georgian architecture. West Campus, Gothic in style and dominated by the soaring 210-foot tower of Duke Chapel, opened in 1930. East Campus served as home of the Woman's College of Duke University until 1972, when the men's and women's undergraduate colleges merged. Both men and women undergraduates now enroll in either the Trinity College of Arts & Sciences or the Pratt School of Engineering. In 1995, East Campus became the home for all first-year students.

Duke maintains a historic affiliation with the United Methodist Church.

Home of the Blue Devils, Duke University has about 13,000 undergraduate and graduate students and a world-class faculty helping to expand the frontiers of knowledge. The university has a strong commitment to applying knowledge in service to society, both near its North Carolina campus and around the world.

Mission Statement

Duke Science"James B. Duke's founding Indenture of Duke University directed the members of the University to 'provide real leadership in the educational world' by choosing individuals of 'outstanding character, ability, and vision' to serve as its officers, trustees and faculty; by carefully selecting students of 'character, determination and application;' and by pursuing those areas of teaching and scholarship that would 'most help to develop our resources, increase our wisdom, and promote human happiness.'

“To these ends, the mission of Duke University is to provide a superior liberal education to undergraduate students, attending not only to their intellectual growth but also to their development as adults committed to high ethical standards and full participation as leaders in their communities; to prepare future members of the learned professions for lives of skilled and ethical service by providing excellent graduate and professional education; to advance the frontiers of knowledge and contribute boldly to the international community of scholarship; to promote an intellectual environment built on a commitment to free and open inquiry; to help those who suffer, cure disease, and promote health, through sophisticated medical research and thoughtful patient care; to provide wide ranging educational opportunities, on and beyond our campuses, for traditional students, active professionals and life-long learners using the power of information technologies; and to promote a deep appreciation for the range of human difference and potential, a sense of the obligations and rewards of citizenship, and a commitment to learning, freedom and truth.Duke Meeting

 “By pursuing these objectives with vision and integrity, Duke University seeks to engage the mind, elevate the spirit, and stimulate the best effort of all who are associated with the University; to contribute in diverse ways to the local community, the state, the nation and the world; and to attain and maintain a place of real leadership in all that we do.”

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