MANAGER, CLINICAL DATA OPERATIONS, DCRI

Company: Duke Clinical Research Institute
Location: Durham
Posted on: April 16, 2024

Job Description:

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.Position Summary

The Manager, Clinical Data Operations - Data Solutions serves as a member of the functional group leadership team and is an internal expert resource regarding clinical research informatics and data management methods. This position extends the Director and Associate Directors operations management practices across the group and independently leads functional group initiatives and projects. Additionally, this position oversees and directs the data management and informatics operations for assigned research programs. This work includes day-to-day operations, personnel management, financial performance, regulatory compliance, information systems, quality improvement, and strategic planning. The role develops and implements strategies to enhance the performance and capabilities of Data Solutions and ensures the alignment of goals and objectives with the mission, vision, and goals of the DCRI.

** NOTE: This position may have an opportunity to work remotely. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut



Position Responsibilities

Provide Central Project Management Support

Manage adoption of internal project mgmt. practices

Support PM's/Mgrs on project plans, forecasting and resource allocation.

Coordinate TDS project review

Drive project management tool and software adoption into TDS ops teams

Responsible for Administrative Management of Team

Includes supervisory responsibility for assigning work to others, reviewing completeness & accuracy of work of others, giving recommendations, advice, or guidance to others, completes performance evaluations for direct reports, and making personnel decisions (including promotion, hiring & disciplinary actions).

Manages informatics staff, supports and contributes to the administrative processes for the Informatics group and overall department.

Lead functional group-specific change management and operational readiness initiatives

Conduct ongoing market research and vendor assessments to keep us on front edge of leveraging the data/tech ecosystem

Ensures appropriate departmental infrastructure and systems are in place to support new lines of service.

Ensures that appropriate operational plans are developed and integrated for new data management lines of service performed by Data Solutions, including work flow, trial-specific work instructions, documentation, quality control, roles and responsibilities, and timelines.

Develops forecasts regarding workload volume and makes recommendations regarding staffing in order to optimize efficiency for new lines of service.

Provide central support for SME technical and business analysts and activities for developing new lines of service.

Serve as SME business analyst on assigned service lines

Work with vendors developing software to support data collection, management and data integrations

New Opportunity Management

Manage solution design team activities and support the proposal development process

Department Leadership and Support

Support Dir/AD's in FG goals and initiatives

Function as extended member of leadership team

Education and Experience

BA/BS degree; Master's degree preferred. Minimum of 5 years of project management experience, primarily in a clinical research, informatics or technical environment, required.

Experience in managing projects in a clinical research/clinical data management systems environment is highly desirable.



Skills, Training and Certifications:

* Knowledge of project management techniques and tools.

* Project Management Professional certification desirable.

* Proven experience in risk and change management.

* Proficient in the use of project management software.

* Familiarity with process definition and improvement methodologies and experience in managing process improvement initiatives desirable.

* Experience in a clinical research environment and familiarity with clinical data management and healthcare research informatics processes, and related healthcare/research standards desirable.

* Excellent verbal and written communications skills.

* Strong planning and organizational skills.

* Strong analytical and problem-solving skills.

* Ability to manage multiple projects concurrently and to independently set and communicate priorities.

* Strong leadership, negotiation and conflict management skills.





Minimum Qualifications





Education

Bachelors degree in a related field, Masters degree is preferred



Experience



Minimum of 8 years of directly related data management experience. Experience managing department subgroups, functional or therapeutic areas, including oversight of management personnel are highly valued.
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.

Keywords: Duke Clinical Research Institute, Durham , MANAGER, CLINICAL DATA OPERATIONS, DCRI, Executive , Durham, North Carolina