MANAGER, CLINICAL DATA OPERATIONS, Pragmatic-HSR
MANAGER, CLINICAL DATA OPERATIONS, Pragmatic-HSR
The Manager, Data Operations, serves as an internal expert resource regarding data management operations, including programming, and as a member of the operational leadership team of PHSR. This position oversees and directs the day-to-day operations, personnel management, information systems, quality improvement, strategic planning for PHSR data operations, including maintenance, availability and security of data assets. He/she develops and implements strategies to enhance the performance and capabilities of PHSR Data Operations. The Manager, Data Operations assists with the development of operational plans and monitors the progress and performance of data management and programming services for all PHSR research projects; to include service quality, effectiveness, data integrity, timeliness of deliverables, and adherence to budget.
- Serves as an internal expert resource for all DCRI faculty and staff with regard to PHSR data management and programming services.
- Develops, implements, and maintains efficient approaches to acquisition, maintenance and characterization of research datasets collected from distributed research networks, payers, and other health systems.
- Oversees the development and implementation of workflow and operational processes across all projects and achieve optimal efficiency.
- Collaborate with other functional groups, internal and external and manage vendors, including scope development and management of deliverables, to achieve research aims and departmental goals.
- Devises optimal data collection strategies based on research aims. Determines and approves situations in which deviations from established processes are appropriate.
- Identifies and make recommendations regarding equipment (capital and non-capital), facilities, and space required to support PHSR data operations.
- Ensures that appropriate operational plans are developed for the data management component of all research projects to be performed by PHSR including work flow, trial-specific work instructions, documentation, quality control, roles and responsibilities, and timelines.
- Monitors the progress and performance of all research projects on an ongoing basis and ensures that services performed are in accordance with agreed upon timelines, quality standards, and applicable regulatory requirements and within budgetary limits.
- Ensures that delays are identified and that appropriate interventions are implemented to meet timelines.
- Identifies operational problems, issues, obstacles, and barriers across all projects based on metrics data, and input from project leaders, PIs, project team members, and sponsors.
- Analyzes patterns and trends, prioritizes opportunities for improvements, and facilitates efforts to implement enhancements to processes and systems.
- Oversees quality improvement initiatives within PHSR and provides leadership for cross functional and organizational initiatives.
- Establishes appropriate measures of workload volume, productivity, utilization, and service quality.
- Establishes and oversees appropriate quality control activities to ensure that all data management and programming services meet established quality standards.
- Ensures that functional group operations are in compliance with regulatory requirements, SOPs, and best practices. Identifies gaps in SOP and work practice documentation; develops and implements plans to fill the gaps.
- Performs technical and business analyst activities for developing data operations services, including use of EHR and payer data for use in health services and clinical research.
- Provides the expertise and leadership for defining data and programming project requirements, considerations and effective implementation options, and coordination of appropriate resources. Assist in the design and implementation of complex projects.
- Provides input for creation and maintenance of department work processes.
- Identifies process trends across projects, underlying root causes and improvements for efficiency.
- Supervises and directs staff, providing oversight to personnel activities including, but not limited to, recruitment and hiring, scheduling and work assignments, coaching and disciplinary action, promotions, and transfers.
- Implements strategies and programs to optimize employee satisfaction and morale, including employee reward and recognition programs.
- Oversees all components of the Performance Partnership Systems including performance plans, coaching and feedback, performance evaluations, and development plans.
- Conducts regular staff meetings and ensures that staff are kept abreast of departmental and organizational activities, goals, policies, procedures, and priorities.
- Develops forecasts regarding workload volume and makes recommendations regarding staffing requirements in order to fulfill all project deliverables while ensuring optimal efficiency and quality.
- Provides input in the development and use of cost standards for PHSR data and programming services. Reviews and revises cost standards as needed.
- Prepares budgetary forecasts for functional group expenses (operating and capital).
- Ensures appropriate utilization of resources and adherence to targets.
- Monitors expenditure of funds relative to budget, provides appropriate justification for variances, and ensures that appropriate interventions are implemented.
- Ensures alignment of PHSR operational goals and objectives with the mission, vision, and goals of PHSR, the health services domain, and DCRI.
- Keeps abreast with emerging developments and trends in the field of data management and health services research through participation in professional organizations and review of the literature; applies learnings to PHSR service offerings.
- Facilitates the implementation of strategic plans for the future direction of PHSR to ensure the DCRI's continued position as a leading provider of health services research.
- Facilitates the implementation of new services to be offered by PHSR to meet research needs.
- Represents functional group in sales presentations and other interactions with sponsors.
- Provides input into marketing and sales materials (slide presentations, brochures, etc.) regarding the functional group capabilities and services.
- Provides input into the development of bids, proposals, and grants for the functional group.
- Ensures that proposed services reflect the needs of the sponsor and that budgets are efficient and competitive.
- Defines project resource requirements, assembles and coordinates project staff.
- Oversees forecasting and resources for projects and initiatives.
- Provides direction and support to project team.
- Assures project specific orientation and training, effectively communicates and sets expectations and assures that staff is qualified by education, training and experience to perform their project role.
- Defines, develops and monitors training plans for data management and programming team.
- Coaches for successful completion of tasks.
- Mitigates team conflict and communication problems.
- Executes department strategic planning efforts and communications.
2337 MANAGER, CLINICAL DATA OPERATIONS
Job Family Level
Full Time / Part Time
Regular / Temporary
Bachelors degree in a related field, Masters degree is preferred
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.
- Knowledge of project management techniques and tools.
- Project Management Professional certification desirable.
- Proven experience in risk and change management.
- Familiarity with process definition and improvement methodologies and experience in managing process improvement initiatives desirable.
- Familiarity with SAS and RDBMS tools, including analytics and visualization software, is desirable.
- Experience with vendor management is 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.
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
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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.