Novan
  • 09-Aug-2018 to 31-Oct-2018 (CST)
  • Morrisville, NC, USA
  • Full Time

Purpose:

The Director of Essential Document Management is responsible for the delivery and maintenance of all aspects of collection and archival of clinical essential documentation to meet GCP regulations of clinical study electronic trial master files (eTMF).  This individual will direct the eTMF vendor, multiple CRO vendors and partner with cross functional clinical study team members to develop and implement an eTMF processes, and manage the quality control of the eTMF.  The individual will ensure GCP audit readiness of the eTMF and support all internal and external audits of the eTMF.  This position shall adhere to the Company's quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description.

 

Principal Responsibilities and Accountabilities:

  1. Responsible for eTMF vendor management, incorporating input from clinical operations, and the appropriate identification and archival of all clinical essential records. This effort includes establishing the processes and maintenance/review of essential clinical records.
  2. The individual will effectively oversee contributions of CROs/vendors/Novan study team members to ensure timely delivery of quality clinical essential documentation per GCP regulations.
  3. The individual will define performance metrics and will communicate directly with vendors and study team members to execute aspects of eTMF timelines, and budgets, in context of metric driven performance.
  4. The individual will foster a team work environment to ensure timely and high-quality deliverables.
  5. The individual will collaborate with Clinical Outsourcing to develop an eTMF budget, and manage within the budget, be responsible for providing accrual information and identification of additional costs associated with eTMF maintenance.
  6. The individual will oversee timelines and identify risk factors, risk mitigation strategies to ensure successful maintenance of eTMF during study conduct and archival of study documentation.
  7. The individual will continue to identify gaps in existing SOPs related to document management and develop and implement SOPs to address the gaps in process.
  8. Provide updates and status reports to the SVP, Clinical Operations on a regular basis; report on performance against outsourcing plans for quality, timelines and budget.

 

Qualifications:

  1. Education
    • Bachelor's degree in Life Sciences/or related field required; Master's degree in health care related profession viewed favorably.
  2. Experience
    • 10+ years' experience in drug development with experience across all phases of clinical trial execution, as a clinical sponsor or provider
    • Solid content understanding of clinical essential documentation
    • Knowledge of ICH E6 (R2) and GCP regulations
    • Expertise in understanding the technology platforms utilized to support eTMF and data systems
    • Experience in effectively managing CRO relationships
    • Experience in delivering within a matrix-structured organization.
  3. Skills
    • Demonstrated leadership skills; ability to establish excellent collaborative internal and external relationships; ability to motivate and lead high performing teams.
    • Excellent analytical skills and scientific comprehension and writing skills.
    • Strong interpersonal skills, effective written and verbal communication, and oral presentation skills.
    • Effective problem solving and decision making skills and ability to interact with all levels of management.
    • Ability to anticipate future trends and engage in new, forward-thinking approaches.
    • Advanced proficiency utilizing standard business tools to manage resources and projects (e.g. MS Project, Excel and PowerPoint) with emphasis on MS Excel.

 

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

In the typical office environment requirements include:  reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds.  Occasional travel up to 20%.

 

Novan, Inc. maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.

 

EEOC Statement:

Novan, Inc. is an equal opportunity employer and actively seeks candidates from diverse backgrounds including women, communities of color, the LGBT community, and people with disabilities.

Novan
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