Description
We are seeking a Clinical Data Specialist to join our Clinical Data Management (CDM) team. As a Clinical Data Specialist, you will provide basic and some comprehensive data management expertise to the CDM team to provide efficient, quality data management products that meet customer needs. You may also undertake team leadership activities under the supervision of other Subject Matter Expert (SME), Data Team Lead (eArch Lead), or Functional Manager.
Essential Functions
- Serve as a Clinical Data Specialist (CDS) with guidance.
- Conduct post lock activities (eArchiving, Hyperlinking) activities.
- Conduct all activities in accordance with standard user manuals and working instructions.
- Perform comprehensive quality control procedures.
- Comply with timelines set out by PLA Lead.
- May conduct data review.
- Interact with all team members to negotiate timelines and responsibilities.
- Develop and maintain good communication and working relationships with global eArchiving team and management.
- File preparation for regulatory submission and site audits.
- May serve in the role of back-up to a SME or PLA Lead.
Qualifications
- Bachelor's Degree Clinical, biological or mathematical sciences, or related field.
- Equivalent combination of education, training and experience in lieu of degree.
- Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients.