Clinical Trials Project Leader II

North Carolina, United States
09 Oct 2018
End of advertisement period
09 Dec 2018
Contract Type
Full Time

CTSI-Clinical & Translational Sci Awards

Job Description


The position will provide project management and operational leadership essential to the successful management of CTSI Accelerator ( research programs and projects.The Project Leader will utilize best project management practices andknowledge of the scientific,technical, and clinical requirements to achieve project goals for translational research projects.


Provide project management and operational leadership essential to the success of CTSI Accelerator translational research programs and projects. Develop, coordinate, and implement research and administrative strategies essential to the successful management of translational research projects.

General Project Management Responsibilities:

  • Work collaboratively with Principal Investigators to develop overall program/projectplan. Provide oversight for delivery of project objectives. Serve as a resource to faculty and laboratory staff in identifying and accessing the appropriate complement of resources, collaborators and support needed to achieve their goals, identify potential obstacles, and collaboratively solve emerging problems.
  • Ensure projects are conducted in compliance with applicable regulatory requirements and institutional standards, including IRB and IACUC submissions, as well as the established budget, timelines,and sponsor specifications.
  • Schedule and facilitate regular project team meetings, effectively communicate relevant project information to CTSI leadership, and tactfully communicate difficult/sensitive information to stakeholders.
  • Identify operational problems, issues, obstacles, barriers, and lessons learned across the assigned projects and make recommendations to CTSI leadership regarding solutions and process/system improvements.
  • Ensure project documents are complete, current, and stored appropriately.
  • Prepare status reports and track desired metrics for inclusion in periodic progress reports.
  •  Contribute to improvements of systems, tools, and processes used in project management practices(timeline, financial, reporting, project communication, and review standards) for translational initiatives across the CTSI.
  • Supports contract/legal requirements for projects, including data source use.
  • Ensure appropriate quality assurance and quality controls plans are in place, at an appropriate level for all projects.

Data Science/Analytics:

  • Work with Investigators and data scientists to define data science requirements,considerations and effective implementation options utilizing novel or complex data systems and coordination of appropriate resources. Assist investigators with navigating access to data sources. Assist investigators with navigating access to quantitative research method resources.
  • Regulatory: Work with Investigators and Office of Regulatory Affairs and Quality (ORAQ) to assist investigators in determining the regulatory requirements that might apply to their research, consult on CMC considerations and preclinical studies required prior to submission of an IND/IDE, determine applicability of GLP and GMP requirements in anticipation of a future IND/IDE submission, anticipate regulatory and related obstacles,interface with regulatory authorities, identify appropriate resources for addressing regulatory issues, facilitate collaborative interactions between investigators and other stakeholders and institutional resources.
  • Drug/device/diagnostic optimization, synthesis, and manufacturing: Provide guidance to Investigators and manage outsourcing requirements.
  • Preclinical development: Identify and help establish agreements needed to perform the preclinical studies within Duke, with external commercial vendors, or through other collaborations (e.g. other institutions,NIH-fundedresources, etc.)
  • Clinical Development Plans: Organize scientific advisory boards to develop clinical strategies for translating basic science discoveries to improvement of patient care.
  • Licensing and Ventures: Work with Duke Investigators and the Duke Office of Licensing and Ventures (OLV) to translate academic discoveries into commercial products that benefit society, impact public health,and improve the quality of life. This includes proving guidance for submitting invention disclosure forms, preparing materials for potential licensees/investors, and providing guidance for new company creation.
  • Sponsored Research Proposals: Assist with development of proposals and budgets for sponsored research awards and collaborations. Assist in the identification of additional funding, collaborative, and entrepreneurial opportunities.
  • Subcontracts and Vendor Management: Oversee the execution and monitoring of agreements with non-Duke entities serving as subcontractors or vendors.
  • Financial and Compliance Reporting: Ensure appropriate legal and procurement documents are in effect. Work closely with CTSI Finance to monitor and forecast expenditures, ensure timely and accurate invoicing, and monitor receivables for projects. Work closely with the CTSI Grants Manager to ensure compliance with institutional, state, and federal policies.

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.

Preferences, Knowledge, and Skills

Five years of progressively responsible experience in scientific project management in drug discovery and development.

  • High capacity to build strong relationships with a variety of stakeholders including faculty members/investigators, technical/professional staff and biotechnology interests.
  • Proven track record in project management, planning, prioritization and organizational skills.
  • Proven track record in drug development, pre-clinical, clinical research, clinical operations, data science/analytics and/or regulatory is required. Experience in GLP, GMP and GCP is desired.
  • Experience in intellectual property considerations and commercialization development is strongly preferred.
  • Strong interpersonal, communication, and presentation skills.
  • Ability to manage competing and changing priorities and multiple tasks under inflexible timelines.
  • Strongly prefer candidates with experience in data science/analytics strategy and management.
  • Strongly prefer candidates with grant writing experience.
  • An individual who will be successful in this position should bring refined hands-on laboratory experience, direct experience developing in vitro and in vivo models for drug development, direct experience in and a good working knowledge of early translation into the clinical setting, good working knowledge of data science/analytics strategy and entrepreneurial experience in start-up mode.

Requisition Number 401481653
Location Durham
Job Family Level 78
Exempt/Non-Exempt Exempt
Full Time / Part Time FULL TIME
Regular / Temporary Regular
Shift First/Day

Minimum Qualifications

Duke University 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 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.


Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant(PA) or Pharmacist plus three years of healthcare experience; or one ofthe following equivalents:1. Completion of an allied health degree (e.g., RespiratoryTherapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus aminimum of six years healthcare experience; or2. Completion of a master's degree in Public Health, HealthAdministration or a related area with two years directly relatedclinical trials research experience; or3. Completion of a bachelor's degree plus a minimum of four yearsdirectly related experience in clinical trials research; or4. Completion of a bachelor's degree plus a minimum of five yearsclosely related research experience.**State of North Carolina license may be required.**



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