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

Direct the MC3 Project Office. Oversee the Project Managers in the Office. Oversee

portfolio of MC3 Strategic Projects to ensure progress towards goals. Apply project

management tools to effectively communicate information across the teams, track

progress and develop and implement action plans to troubleshoot and address issues.

Organize review meetings and conduct cross functional team meetings as needed.

WORK PERFORMED:

40% Direct the MC3 Project Office. Supervise the Project Managers (PMs) in the Office.

Provide guidance to PMs and establish overall direction for the projects. Manage

personnel actions for the Project Office, including, but not limited to, hiring, performance

appraisals, promotions, and vacation schedules. Oversee portfolio of MC3 Strategic

Projects to ensure progress towards goals. Apply project management tools to

effectively communicate information across the teams, track progress and develop and

implement action plans to troubleshoot and address issues. Organize review meetings

and conduct cross functional team meetings as needed. Take a proactive role to

increase the productivity, efficiency, and organization of the projects managed by the

Project Office. Proactively identify issues that could impact the successful execution of

projects and elevate issues to MC3 Leadership. Provide suggestions to resolve the

problem/mitigate the risks.

20% Manage project tracking and program evaluation. As Director of the MC3 Project

Office, provide coordinative oversight to MC3 projects as needed. Advise and assist

MC3 team members in the development of plans, time lines, and processes for projects

as needed. Apply project management tools to effectively communicate information

across the teams. Organize review meetings and conduct cross functional team

meetings as needed. Provide materials for update to MC3 Leadership. Assist with

implementing, maintaining, and assisting management with the balanced scorecard.

40% Directly manage projects as needed. Portfolio of projects could include clinical

trials projects, IT and data management projects, tech transfer projects, process

development projects or any other critical project for MC3.

a) Clinical trials management: Manage multi-site and single site clinical trials.

Negotiate site budgets and contracts, pre-screen clinical sites, write training

documents and train processing labs, conduct Site Initiation Visits (SIVs), select

and manage CRO and/or contract CRAs, manage the development of data base

and CRFs, randomization schedules and modules. Coordinate with Duke legal

to set up site contracts as needed. Act as main point of contact for external

sites. Act as coordinating center for MC3 multi-site studies. Coordinate among

multiple stakeholders to achieve successful study initiation, completion and

close out. Coordinate with statistician to create randomization schedules and

sampling plans. Manage statistician, Data safety Monitoring Board (DSMB), and

data management services to create and review data reports. Write DSMB

charter and select and train DSMB members. Coordinate with MC3 manufacturing labs and Duke and external clinical sites, for the distribution of cellular products undergoing testing in MC3 clinical trials. Assist with writing of clinical protocols, INDs, BLA documents. Review regulatory reports, review data submitted to INDs. Monitor status of ongoing trials and outcomes. b) IT and Data Projects Management: Manage IT and data management projects for the Marcus Center for Cellular Cures. Lead the implementation of new software in FDA-regulated, GMP environment to support critical operations of the Center. Select vendors and manage the contracting process. Coordinate with all stakeholders to develop implementation plans. Determine functionality of the new systems and develop procedures and CRFs as needed. Manage migration from existing systems. Oversee implementation of the installation or upgrade. Develop and/or modify SOPs for the new systems and work with the Operations team to update the Operations SOPs as needed. Manage training of personnel on the new systems. Oversee IQ/OQ/PQ, writing and implementing validation plans as needed. Write regulatory documentation as needed for the validation and approval of these systems. Write validation protocols and perform or oversee the performance of IQ/OQ/PQ for these systems. c) Tech Transfer or Process Development Projects: Coordinate cross functional teams to manage progress on projects. Act as main point of contact for key external stakeholders. Develop aims, track progress and manage deviations. Alert senior leadership of problems and develop course of action to address issues. Communicate with all stakeholders. 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.

Education

Work requires a bachelor’s degree plus a minimum of seven years of experience in

project management.

Experience

None required beyond that described above.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Requirements

· Project leadership and management experience required

· Experience in multicenter clinical trials and/or FDA / GMP setting required

· Demonstrated ability to operationally manage several projects concurrently

· Attention to detail

· Excellent people skills

· Ability to work well under pressure

· Excellent communication skills, both spoken and written. Experience communicating with senior executives

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Education

Bachelor's degree in English, communications, science, business or a related field. Advanced degree is highly desirable with demonstration of an understanding and familiarity with a broad range of science or technical subject matter.

Seven years of experience working with extramural grants and contracts. 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.