Clinical Operations Manager

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

📋 Description

• Act as the operational leader and subject matter expert for Clinical Trial Associate functions within Clinical Monitoring.

• Collaborate with leadership to execute operational strategies, departmental goals, and enhance processes.

• Manage resource forecasting and workload evaluations for the CTA team.

• Offer functional leadership, guidance, mentoring, and daily support to CTA personnel.

• Assist in the onboarding, training, and professional growth of CTA staff.

• Authorize time reporting and expenses for direct reports.

• Identify and resolve CTA operational challenges in collaboration with Monitoring leadership.

• Work alongside Project Managers, CTMs, and CRAs to synchronize CTA activities with project plans and study timelines.

• Track CTA performance metrics and operational indicators.

• Aid in ensuring inspection readiness and audit preparedness.

• Provide operational oversight of CTA deliverables to ensure quality and compliance.

• Spearhead standardization, optimization, automation, and continuous improvement initiatives.

• Assist in the development and maintenance of SOPs, work instructions, training materials, and operational tools.

• Encourage effective utilization of CTMS, eTMF, and other clinical technologies.

• Identify operational risks and propose solutions.

• Supervise CTA support during study startup, maintenance, and closeout processes.

• Guarantee that study documentation and TMF activities are complete and ready for inspection.

• Ensure adherence to sponsor requirements, SOPs, ICH-GCP guidelines, and regulations.

• Occasionally provide assistance on study projects that require additional oversight of junior team members or more resources.

⛳️ Requirements

• Bachelor’s degree with 5 years of clinical research experience, or equivalent combination of education, training, and experience; years of experience may be considered in lieu of education.

• At least 1 year of management or leadership experience, preferably within a CRO environment.

• Significant clinical operations experience in clinical trials, especially using Ora processes and tools such as Veeva Vault eTMF and CTMS, ICH GCP, DIA TMF Reference Model, and regulatory guidelines/directives is highly preferred.

• Demonstrated capacity to lead multifunctional teams and mentor junior clinical operations staff.

• Prior experience in a CRO setting is strongly preferred.

• Ability to inspire, lead, or mentor a team while identifying and acting on coaching opportunities.

• Comprehensive understanding of regulatory requirements and their implications for clinical operations.

• Experience managing external partnerships and relationships, including sites, vendors, and sponsors.

• Detailed knowledge of regulatory requirements and ICH/GCP guidelines for clinical trial documentation and records management.

• Extensive clinical operations experience in ophthalmology clinical trials.

• Proven ability to work independently, take initiative, and meet deadlines.

• Excellent communication skills with internal teams, sponsors, and external vendors, including issue escalation, training, and responding to inquiries and concerns.

• Capability to set goals, create structure, and maintain a focused and collaborative approach to delivering timely, high-quality work.

🏝️ Benefits

• Comprehensive medical, dental, and vision healthcare options starting from day 1.

• Flexible PTO.

• Unlimited sick leave.

• 14 company-paid holidays.

• 401(k) plan through Fidelity with company match.

• Adoption assistance.

• Fertility assistance.

• 16 weeks of paid parental leave.

• Company-paid life insurance.

• Company-paid disability insurance.

• Remote workspace reimbursement.

• Wellness reimbursement.

• Employee Assistance Program.

• Career development opportunities.

• Opportunities to collaborate with colleagues worldwide.