Clinical Operations Lead

This is a fully remote position, open to applicants in Germany.

📋 Description

• Accountable for managing the clinical operations of a project at a specified regional or global level.

• Oversees project deliverables, including the assigned Clinical Research Associates (CRAs) and Investigator sites, in line with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines, and local regulations.

• Serves as the primary point of contact between the CRAs and the clinical project team.

• Additional duties encompass project-specific training for CRAs, conducting assessment visits with CRAs, implementing enrollment and recruitment strategies, and preparing the monitoring plan along with other structural documentation.

• Manages the scheduling of monitoring visits, site and monitoring performance metrics, issue escalation, and corrective actions.

• The Clinical Operations Lead (COL) will create study tools for both site and CRA utilization, review visit reports, track protocol deviations, and assist with other objectives related to clinical operations and the clinical project team.

⛳️ Requirements

• A college diploma or degree accompanied by 7-9 years of relevant experience, along with continuous training and skill enhancement.

• Alternatively, an undergraduate university degree (Bachelor's or Honors Bachelor's) with 4-6 years of experience and significant ongoing job-related training.

• Preference for candidates with a background in Health Sciences, Life Sciences, or Nursing, or those holding SoCRA and/or ACRP Certification/Designation.

• Must have a minimum of 3 years of CRA experience, strong familiarity with EDC systems, proficiency in MS Office, and excellent written and verbal communication skills, along with highly effective interpersonal and organizational capabilities.

• Should exhibit the following qualities: proactive, detail-oriented, task-driven, and exceptionally organized.

• Must demonstrate a thorough understanding of GCPs and local regulations as they pertain to clinical monitoring, IRB/EC, and Investigator responsibilities.

• Proven ability in report writing and a strong capacity to critically analyze clinical research documents.

• Capable of managing multiple tasks to meet deadlines in a fast-paced environment.

🏝️ Benefits

• Bonus