PROGRAM MGR, CLINICAL DATA MGMT

Employer
Duke University
Location
Research Infrastucture & Administration
Closing date
Oct 23, 2021

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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.

Cancer Center Support Grant Team [CCSG]

Position Description

Occupational Summary

Responsible for meeting the clinical trial reporting processes and standards of all governing bodies such as the National Institutes of Health (NIH), the National Cancer Institute (NCI) and the Internal Review Board [IRB] for oncology clinical trials the DCI and all Duke departments.

Work Preformed

Data and Quality

Develop, coordinate, and implement administrative and operational improvements in data collection, metrics for QA and QC, data reporting of oncology clinical trials.

Subject matter expert for information entered into the clinical research management system.

Originate and maintain CTRP submissions of new trials, amendments, status changes and updates, and subject accruals. Serves as point of contact for the NCI on behalf of DCI for clinical research data submission Responsible for ensuring clinical trial data comply with the requirements of the governing bodies.

Responsible for accurate clinical trial data in all systems such as OnCore, the Clinical Trial Management System (CTMS), and Clinical Trials Reporting Program [CTRP].

Analyze data to identify adverse trends and undesirable performance. Utilize performance improvement techniques and methodologies to devise improvement strategies.

Conduct quality assurance checks across multiple systems to identify outliers, missing and conflicting data; address and rectify those discrepancies.

Reporting

Responsible for accurate and timely internal and external clinical trial data reports. Responsible for NCI and CCSG data reports.

Facilitate clinical research metrics reporting and presentations for DCI Leadership; including but not limited to Tableau Research Dashboards.

Ensure all oncology research is reported to the NCI in accord with requirements set forth by the NCI, Food and Drug Administration (FDA), university, sponsors, Institutional Review Board (IRB), departmental SOPs, and other regulatory bodies.

Leadership

Develop strong collaborative professional relationships within the DCI, across Duke and colleagues across the country to develop and manage clinical trial reporting needs.

Point of contact for the NCI on behalf of DCI for clinical research data submission.

Facilitates and collaborates with Executive Leadership for CCSG write-ups, reports, and future renewals.

Ethics

Know and follow policies, standard operating procedures (SOPs), regulations and protocol requirements that govern clinical research. Maintain Duke and project specific training and certification requirements.

Other work as assigned.

The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.

Skills

  • Clinical trial management systems knowledge and experience
  • Knowledge of technical research protocols
  • Grant writing skills
  • Possess a high attention to detail (both written and verbal) and analytical abilities.
  • Familiarity with federal agency policies, regulations and accounting.
  • Ability to collaborate in a responsible, values-driven, high-quality and cost-effective way
  • Exceptional analytical, leadership and communication abilities.

Preferences

The preferred candidate will have experience in an academic research organization and NIH or NCI grant administration.

Qualifications Required At This Level

Education/Training

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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