Novan
  • 09-Aug-2018 to 08-Oct-2018 (CST)
  • Morrisville, NC, USA
  • Full Time

Purpose:

The Clinical Data Manager contributes to the clinical development of investigational drugs by providing expertise, expectations, direction and oversight for Clinical Data Management (CDM) deliverables and activities within and across studies.  Takes a lead role with internal and external partners and represents the company at meetings with clinical investigators and in the interaction with Contract Research Organizations (CROs) and external vendors in all aspects of data management.  Develops CDM standards and processes, provides strong leadership in data-driven centralized monitoring, and supports pharmacovigilance activities.  

 

Principal Responsibilities and Accountabilities:

  1. Perform duties on site, on time, and within the Company's normal business hours listed in the Employee Handbook. Facilitate frequent interactions with co-workers and conduct timely problem-solving meetings necessary to address critical and emerging work issues.  Presents a positive attitude to create and maintain productive working relationships with fellow employees and vendors.
  2. As a key Clinical Development team member, establish, align and confirm data management expectations for individual trials, through regular interaction with Clinical Operations, Biostatistics, Quality Assurance, Regulatory, and Outsourcing.
  3. Responsible for CDM trial level oversight. Builds effective relationships with CROs and vendors. Review protocols and identifies requirements for proper data capture including electronic Case Report Form design and processing of clinical data ensuring accuracy, consistency and completeness
  4. Oversee the design, creation and UAT Plan and testing of clinical study databases along with development of edit check specifications and manual data listings, as required.
  5. Define or reviews creation and maintenance of all essential data management documentation including CRF specifications, eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans (detailing complete data management processes throughout clinical studies), Data Transfer specifications and Data Review Guidelines, in accordance with the protocol and company standards.
  6. Integrates external data (non-CRF data) from vendors or other internal departments into the clinical trial database.
  7. Establishes conventions and quality expectations for clinical data and plans and tracks the content, format, completeness, quality and timing of the trial data collection process and other CDM deliverables via data analytics throughout the conduct of a trial.
  8. Collaborates with the trial team to ensure that the database can be locked according to the planned timelines and quality. Responsible for the database lock and accountable for the integrity of the database.
  9. Ensures compliance with CDISC standards for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM)
  10. Supervises and instructs the CRO in performing the above DM tasks and leads trial level oversight.
  11. Ensures clinical data are organized, well-documented, and archived per company's procedures.
  12. Contributes to the development of a centralized (data-driven) monitoring plan with Clinical Operations, biostatistics, and QA.
  13. Implements the centralized monitoring plan by producing reports with Statistical Analysis Software (SAS) and communicating findings to Clinical Operations.
  14. Performs simple data queries and analyses of completed studies to assist Clinical Operations in study planning.
  15. Using SAS, independently validates ad hoc statistical analyses for regulatory and publication purposes

 

Qualifications:

  1. Education
    • Bachelor's degree or master's degree from an accredited institution with a major/focus in Life Sciences, Computer Science, Statistics, or similar preferred.
  2. Experience
    • At least 5 years of experience in clinical research including data management and/or clinical trial management required. Experience within the pharmaceutical industry preferred.
    • Ability to program SAS independently
    • Familiarity with ICH-E6 (R2) and experience with centralized (data-driven) monitoring and oversight
  3. Skills
    • Ability to identify and communicate trends
    • Significant experiences with Electronic Data Capture (EDC) systems and processes
    • Critical thinker with great attention to detail
    • Excellent organizational skills, problem solving abilities, negotiation skills, time management skills and initiative.
    • Must be able to work independently as well as part of a team.
    • Able to effectively manage multiple assignments and adapt flexibly to changing priorities.
    • Strong communication skills with the ability to simply summarize complex information.
    • Ability to work collaboratively on multi-disciplinary project teams and to pro-actively manage relationships with external vendors.
    • Good written and oral communication skills in the English language.
    • Ability to lead and facilitate meetings.
    • Ensures all tasks are carried out in accordance with applicable principles of Good Clinical Practice (GCP), Novan Standard Operating Procedures (SOPs), and regulatory guidelines.
    • The qualified applicant shall demonstrate: a) sound reasoning; b) progressive learning agility; c) versatility or being capable of doing many things competently; and, d) resilience from a disappointment or setback.
    • Values achieving milestones, including team and company goals.

 

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.  There will be an occasional requirement to work outside of normal business hours.  Some travel may be required (up to 10%).

 

Novan 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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