Remote
Covance

eClinical Project Leader – II

Job Location(s)US-NC-Raleigh-Durham

Job Number

2019-28597

Job Category

Clinical Data Management

Position Type

Full-Time

Job Overview

Sr Medidata RAVE Developer

permanent, salaried

Remote from anywhere in the U.S. or Canada

Responsibilities

  1. Demonstrate independent judgment and autonomy regarding: triage conflicting responsibilities so that tactically immediate and strategically significant project duties are appropriately addressed; anticipate and address potential barriers to project success; proactively collaborate with colleagues to recommend and implement process improvements.
    2. Lead the design and build of study databases or lead the study SAS programming activities or other Data Management related system
    3. Work in a timely manner in accordance with all the activities specified in the agreed study budget in close partnership with other programming team members and make the DTP and study team management aware of any out of scope activities.
    4. Perform all tasks to relevant Covance and/or Sponsor SOPs, ICH or other regulatory guidelines in DTP
    5. Ensure adherence to project-specific quality and performance standards and ensure that these are adequately documented, communicated and understood.
    6. Provide guidance and training to Level 1 3 colleagues as well as new hires
    7. Perform other duties as required by the Department

Experience Required

  • Ability to maintain the confidentiality of data and information during interactions with staff at all levels
  • Expertise in at least one clinical, e-clinical or safety database system OR Expertise in basic SAS programming skills to perform transfers, external checks, listings and process external vendor data
  • Expertise in clinical coding as it relates to the transfer of data to/from coding platforms.
  • Understanding of the roles of standards, including CDISC

Education/Qualifications

Minimum 6+ years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job

Experience

  • Ability to maintain confidentiality of data and information during interactions with staff at all levels
  • Expertise in at least one clinical, e-clinical or safety database system OR Expertise in basic
  • SAS programming skills to perform transfers, external checks, listings and process external vendor data
  • Expertise in clinical coding as it relates to the transfer of data to/from coding platforms.
  • Understanding of the roles of standards, including CDISC