Clinical Operations Lead: Trials, Budget & Compliance

Parexel; Oregon; Hybrid; USD 110,000 - 150,000; Full time

Job summary

Parexel is seeking a Clinical Operations Manager to oversee country-level clinical trial activity, budgets and regulatory submissions in the United States. The role requires leadership across CRO stakeholders and collaboration with HQ to align timelines and deliverables.

The position emphasizes budget control, vendor management and regulatory engagement, with minimal travel and potential remote work in a hybrid setup. Strong communication and risk management skills are essential.

Qualifications

• Requires strong coordination and organizational skills.
• Experience in budget and contract negotiations for clinical trials.
• Knowledge of local regulatory environments and submission/approval processes.
• Ability to influence investigators, vendors and country managers.
• Ability to work independently with limited supervision, including in remote settings.

Responsibilities

• Manage country deliverables, timelines and results for assigned protocols.
• Coordinate with CRMs, CRAs and CTAs to ensure submissions, budgets and CTRAs.
• Oversee local vendors, processes, and filing; ensure compliance with ICH-GCP and country regs.
• Develop and manage country and site budgets, CTAs and payments; ensure fair market value.
• Interact with IRB/IEC and Regulatory Authorities for submissions and approvals.

Skills

Coordination skills

Budget negotiations

Regulatory knowledge

Influence abilities

Independence in decision making

Remote work adaptability

Job description

Parexel is seeking a Clinical Operations Manager to oversee country-level clinical trial activity, budgets and regulatory submissions in the United States. The role requires leadership across CRO stakeholders and collaboration with HQ to align timelines and deliverables.

The position emphasizes budget control, vendor management and regulatory engagement, with minimal travel and potential remote work in a hybrid setup. Strong communication and risk management skills are essential.