Clinical Operations Manager

Job Description

This position will be based in Riyadh. It is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, company policies and procedures, and quality standards internally and externally. As the Clinical Operations Manager, you will have ownership, oversight, and impact on local regulatory and financial compliance.

• Demonstrates proactive leadership and indirectly influence investigators, vendors, external partners, and country managers to deliver commitments within timelines and budgets with minimal oversight from the line manager.
• Skilled knowledge of budget and contract negotiations, local ethics, legislation, regulatory environment, submission and approval processes, development of local Informed Consent and other site‑ready and ongoing study deliverables.
• Ability to proactively develop risk‑management and mitigation plans in the country and resolve issues locally; independent decision maker with a clear understanding of pros and cons of each decision and takes ownership of decisions.
• Extensive experience with clinical project management and coordination.
• Expertise of core clinical, regulatory, and financial systems, tools and metrics.
• Extensive knowledge of local regulatory environment and submission and approval processes.
• Strong coordination and organizational skills.
• Demonstrates leadership behaviors.

• Problem solving and process improvement is essential.
• Ability to pro‑actively identify issues and risks, analyze root cause, propose solutions to problems and elevate to management as applicable. Examples include budget/CTRA negotiations, quality and compliance issues, regulatory and legal issues, and issues related to functional area deliverables that could jeopardize protocol milestones.
• Strong communication and leadership skills.
• Strong negotiation skills and excellent influencing and training/mentoring skills, both written and verbal.
• People management skills (also across countries) will be valued.
• Ability to focus on multiple deliverables and protocols simultaneously.
• Ability to work effectively in a remote virtual environment with a wide range of people and understanding of cultural differences.
• Fluency in both English and Arabic.

• Required:
  
  10 years of experience in clinical research with at least 7 years of experience in Startup activities in Saudi Arabia.
• Preferred:
  Additional Startup experience in other Middle East Countries.

• Required:
  
  Bachelor’s Degree (or comparable) in Business Finance/Administration/Life Science or equivalent Health Care related degree.
• Preferred:
  Master’s Degree (or comparable certification) in Business Finance/Administration/Life Science/Project Management.

• Budgeting
• Clinical Trial Compliance
• Clinical Trial Documentation
• Clinical Trial Management
• Clinical Trials Monitoring
• Clinical Trials Operations
• Communication
• Contract Agreements
• ICH GCP Guidelines
• Negotiation
• Regulatory Compliance

• Employee Status:
  Regular
• Travel Requirements: (not specified)
• Flexible Work Arrangements:
  Hybrid