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TMF System Specialist, DCRI TRIALS SERVICES SUPPORT

Employer
Duke University
Location
DCRI - Clinical Trials Services

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.

Position Summary:
The TMF System Specialist is a key contributor to the TMF process at DCRI from project set-up through final export for the PhlexEview System. This position is responsible for providing PhlexEview system set-up, maintenance, and closeout services according to DCRI standards and project requirements. The TMF System Specialist is a PhlexEview system and TMF subject matter expert; and provides and guidance to Project Leads and Functional Project Leads in TMF processes and system functionality across multiple projects.

** NOTE: This position can be done remotely for candidates who live in the following states: NC, CA, FL, GA, MD, NY, SC, TN, TX, VA, AND WASHINGTON, DC **

Position Responsibilities & Key Tasks:

PhlexEview and TMF Support

a. Serves as primary point of contact for the “PhlexEview Helpdesk” to address project support issues and resolve user questions regarding the PhlexEview system and Trial Master File (TMF).
Provide user follow-up via email, phone, and/or face to face in a timely and courteous manner.
b. Provides TMF and PhexEview system guidance to users on correct use of the system and associated processes.
c. Identifies issues and problems relating to system functionality or inconsistencies and suggests possible resolution; collaborates with eTMF Business Process Owner and vendor on issue resolution.
d. Troubleshoots and resolves reported issues; triage and escalate to eTMF Business Process Owner and\or vendor.
e. Participate in the development of User Acceptance Testing (UAT) scripts and execute UAT scripts for system change and new functionality (e.g. Change control, upgrades, and patches).
f. Provides guidance on PhlexEview report generation and data listings.

PhlexEview Project Team support

a. Set-up new projects in PhlexEview at trial, country, and site level according to project trial master file requirements and DCRI standards.
b. Implement project level changes when requested.
c. Grant\revoke system access and update roles, including auditor\inspector accesses per defined processes.
d. Conduct Project Meetings for set-up, Quality Review and Close-Out meetings, ensuring Project Teams understand processes and functionality and comply with organizational standards.
e. Support training of the PhlexEview system and TMF practices: deliver training as requested, provide input and review on training materials, and lead eTMF related meetings (e.g. TMF Business Solution Champion meetings).
f. Perform document quality review in PhlexEview. Provide feedback to document uploader as needed.
g. Assist project teams in the preparation for internal\external audits; provide support as requested during audit
h. Contribute to overall health of the eTMF by providing expert guidance and direction on Quality Reviews and completeness configuration following current practices.
i. Provide guidance to project teams in close-out and lock process and perform system admin support processes.
j. Prepare and distribute communications to end user (e.g. system down time)

Process Improvement

a. Contributes and suggests enhancement for PhlexEview system improvement. Collaborates with eTMF Business Process owner and vendor on the change control process.
b. Collaborate with Project Lead and Lead CRA to obtain/share trial specific issues across all study sites with a focus on quality and metrics
c. Participates and supports the development of custom workflows and processes with users, eTMF Business Process Owner and vendor.

DCRI Infrastructure

a. Participate in the development and revision of SOP and guidance documents for PhlexEview and the TMF.
b. Participate in cross-functional efforts toward standardizing processes and maintaining compliance for PhlexEview and the TMF.

PhlexEview and TMF Knowledge

a. Demonstrable and apply knowledge of TMF business process and clinical trial activities required for comprehension and support of company adoption and business processes
b. Maintain a thorough understanding of the TMF Reference Model and stay informed of industry trends for eTMF.

SharePoint eTMF Support

a. Support SharePoint eTMF activities: set-up new projects, create accounts, train users on processes, and sending final TMF export.
b. Identifies issues and problems relating to SharePoint eTMF. Suggests possible resolution and collaborates with SharePoint designer.

Other Duties:
Cross Train and cover for routine requests for the Clinical Trials Management System (CTMS).

Knowledge, Skills and Abilities:

• Previous experience of setting-up and maintaining Trial Master Files.
• Detailed knowledge of TMF related regulatory expectations and requirements.
• Detailed knowledge of the TMF Reference Model.
• Knowledge of clinical development phases and processes desired.
• Previous involvement in TMF audits and/or regulatory inspections
• Previous experience to train, lead and mentor TMF project team members
• Project management skills. Ability to set priorities, organize, and manage multiple planning tasks independently.
• Excellent written and oral communication skills.
• Excellent analytical and quantitative skills.
• Relates well to all levels of staff, approachable and builds constructive and collaborative relationships.
• Self-starter and self-motivated with a willingness to take initiative, seek guidance when needed, and see projects through to completion independently.
• Flexible, adaptable, and comfortable with uncertainty and operating in an entrepreneurial environment.
• Use critical thinking skills to identify effective and efficient solutions for complex problems; to quickly grasp new practices and derive opportunities for improvement
• Excellent computer skills, including ability to quickly learn new software functionality
• Comfortable with software applications (Word, PowerPoint, Excel, and Access).

Minimum Qualifications

Education

Bachelor's degree. Additional training in Project Management or related training is desired.

Experience

Two years of experience in project management, with increasing scopeOR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE and independence.

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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