PROGRAM MGR, CLINICAL DATA MGMT-DCRI

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Position 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. The Program 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 Data Solutions (DS) teams, coordinating several or large projects, and may perform clinical data specialist (CDS) responsibilities on a project, as needed.

** 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

The Program Manager, Data Management is responsible for and provides technical and management oversight for assigned projects. The Program Manager oversees project management through supervision and mentoring of assigned data management staff to ensure that contracted services are performed on schedule, within budget, in compliance with applicable regulatory requirements, and in accordance with sponsor specifications. The individual facilitates problem resolution and issue escalation across therapeutic area projects or programs

Position Responsibilities

Project Management

• Provides direction and input in the development of operational plans for new project proposals, including services that DCRI and DS 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.

Data Coordination

• 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.
• Participates in business development activities such as presentations to prospective sponsors, development of scope of work, and cost estimates across multiple therapeutic areas.
• Maintains a working knowledge of healthcare and research standards; provides leadership in choosing best practices for data management processes, including data management models.
• 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.

Technical

• 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.
• Educates internal and 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.
• Conducts annual and interim individual performance reviews, sets performance goals, provides feedback, and coaches staff.

Education and Experience

BA/BS degree; Master’s degree preferred.  Minimum of 6 years of directly related data management experience, to include at least two years of administrative, supervisory or project management experience.

Skills, Training and Certifications:

Position requires experience managing multiple projects and teams and supervising staff, particularly departmental teams or sub-groups; working knowledge of clinical data management systems and standards; strong analytical and problem-solving skills; ability to manage multiple projects concurrently; strong communication skills in an interdisciplinary clinical research team setting.

Certified Clinical Data Manager (CCDM) designation is strongly recommended.

Minimum Qualifications
Education

Requires a Bachelors degree in Life Science or Biological Science; Masters 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.

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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.