Responsible for the clinical operations of a project within a defined regional/global level.
Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.
Acts as a primary liaison between the CRAs and the clinical project team.
Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.
Develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.

College diploma/degree AND 7-9 years related experience + continuous training and knowledge/skills upgrading
OR Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training
Minimum of 3 years CRA experience.
Strong experience with EDC systems.
Proficient with MS Office.
Strong written and verbal communication skills.
Highly effective interpersonal and organizational skills.
Proactive, detail-oriented, task-driven, and highly organized.
Critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.
Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
Ability to handle multiple tasks to meet deadlines in a dynamic environment.

Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle.
Health Sciences, Life Sciences or Nursing specialty preferred.
SoCRA and/or ACRP Certification/Designation.

Clinical Operations Lead

Key skills