Job Title: Clinical Operations Lead
We are seeking a highly skilled and experienced Clinical Operations Lead to oversee the clinical operations of a project within a defined regional/global level.
This role 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.
The Clinical Operations Lead acts as a primary liaison between the CRAs and the clinical project team, providing operational support and guidance throughout the project.
Additional responsibilities include:
* Project Oversight
* Oversee regional startup and feasibility activities.
* Assist in vendor management activities as required per project.
* Perform review of visit reports for quality, compliance and appropriate site management.
* Ensure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.
The ideal candidate will have a minimum of 7-9 years related experience and hold a College diploma/degree, or an undergraduate university degree AND 4-6 years' experience + substantial on-going job-related training.
The following qualifications are preferred:
* Health Sciences, Life Sciences or Nursing specialty.
* SoCRA and/or ACRP Certification/Designation.
The selected candidate will be proactive, detail-oriented, task-driven and highly organized, with strong written and verbal communication skills and highly effective interpersonal and organizational skills.
We offer a competitive salary and benefits package, and the opportunity to work in a dynamic environment. This is a home-based position.
Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to [insert contact information].