Clinical Operations Manager
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Key skills for this role
About the Role
MSD seeks a Clinical Operations Manager in Riyadh to oversee local clinical trial activities in compliance with ICH/GCP and regulations. The role involves budget negotiations, regulatory submissions, and risk management.
Key Skills for This Role
Responsibilities
- Oversee execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations
- Manage budget and contract negotiations with investigators and vendors
- Develop local Informed Consent and other site ready and ongoing study deliverables
- Proactively develop risk management and mitigation plans in the country
- Resolve issues locally and escalate to management as applicable
Requirements
- 10 years of experience in clinical research with at least 7 years in Startup activities in Saudi Arabia
- Bachelor's Degree in Business Finance/Administration/Life Science or equivalent Health Care related Degree
- Fluency in both English and Arabic
- Skilled knowledge of budget and contract negotiations
- Extensive experience with clinical project management and coordination
- Ability to work effectively in a remote virtual environment
Full Job Posting
Job Description
- This position will be based in Riyadh.
- Accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, policies and procedures, and quality standards.
- Ownership, oversight, and impact on local regulatory and financial compliance.
CORE Competency Expectations
- Demonstrates proactive leadership and ability to influence investigators, vendors, external partners, and country managers.
- Skilled knowledge of budget and contract negotiations, local ethics, legislation and regulatory environment.
- Ability to proactively develop risk management and mitigation plans and resolve issues locally.
- 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.
Behavioral Competency Expectations
- Problem solving and Process Improvement essential.
- Ability to pro actively identify issues and risks, analyze root cause, and propose solutions.
- Strong communication and leadership skills.
- Strong negotiation skills and excellent influencing and training/mentoring skills.
- People management skills valued.
- Ability to focus on multiple deliverables and protocols simultaneously.
- Ability to work effectively in a remote virtual environment with understanding of cultural differences.
- Fluency in both English and Arabic.
Experience Requirements
- Required: 10 years of experience in clinical research with at least 7 years in Startup activities in Saudi Arabia.
- Preferred: Additional Startup Experience in other Middle East Countries.
Educational Requirements
- 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.
Required Skills
- 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
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