DATA MANAGER (CLINICAL)

Location
Durham, NC
Posted
Apr 13, 2017
Institution Type
Four-Year Institution

DATA MANAGER (CLINICAL)
Duke Reading Center

THIS IS A 30/HR/WEEK POSITION

Summary:

Lead data management and project management activities involved in planning, organizing and conducting research studies for assigned trials within the overall scope of data management function.

Work Performed:
  • Data Management (50%):
  • Develop data management planning documents such as Database Design Specifications (DDS)
  • Data Transfer
  • Export Specifications; and case report forms (CRFS) and instructions.
  • Create procedures, user manuals, training materials, and other data management documents for the assigned clinical trials.
  • Communicate with database programmer, sponsors and internal staff regarding study specifics.
  • Prepare reports and correspondence for data management section as needed.
  • Oversee data management personnel and coordinate review teams within the data management section to validate databases by performing User Acceptance Testing(UAT) and Edit Check Testing (ECT).
  • Create data management timelines and monitor adherence to established timelines, as well as, recommend corrective action as necessary.
Project Management (20%):
  • Generate, resolve, and track data queries to assure the integrity of the clinical data with respect to data guidelines and sponsor specifications.
  • Communicate with sponsor or CRO statistical, programming, and clinical departments in identification and resolution of data management or query issues.
Company Representation/Proposal and Budget Development (25%):
  • Represent the company as the clinical data representative in meetings to sponsors, CROs, another vendors.
  • Meetings may occur on a weekly basis.
  • Present demo of internal Electronic Data Capture (EDC) system to prospective clients.
  • Assist with proposal and budget estimates for electronic data capture; database builds and validation; query resolution; and database lock and close out.
  • Provide feedback regarding quality assurance and information regarding detected deficiencies and corrective action needed; follow-up with management and quality assurance until any deficiencies are resolved.
  • 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. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Requisition Number
401156440

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
2344 CLINICAL DATA SPEC II

Job Family Level
71

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, genetic information, gender, gender identity, national origin, race, religion, sexual orientation, or veteran status.

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.

Education

Work requires organizational, analytical and communications skillsgenerally acquired through completion of a bachelor's degree program.

Experience

Work requires three years of directly related data managementexperience.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Auto req ID

82781BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

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.

PI97510214