Clinical Operations Manager
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Key skills for this role
About the Role
This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations. The Clinical Operations Manager will have ownership, oversight, and impact on local regulatory and financial compliance.
Key Skills for This Role
Responsibilities
- Execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations
- Ownership, oversight, and impact on local regulatory and financial compliance
- Proactively develop risk management and mitigation plans in the country and resolve issues locally
- Influence investigators, vendors, external partners, and country managers to deliver commitments within timelines and budgets
- Manage budget and contract negotiations, local ethics, legislation and regulatory submission and approval processes
- Develop local Informed Consent and other site ready and ongoing study deliverables
Requirements
- 10 years of experience in clinical research with at least 7 years of experience in Startup activities in Saudi Arabia
- Bachelor's Degree (or comparable) 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, local ethics, legislation and regulatory environment
- Extensive experience with clinical project management and coordination
- Strong coordination and organizational skills
Full Job Posting
Job Description
- This position will be based in Riyadh.
- This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our company's policies and procedures and with quality standards internally and externally.
- As the Clinical Operations Manager, you will have ownership, oversight, and impact on local regulatory and financial compliance.
Core Competency Expectations
- Demonstrates proactive leadership and must be able to in/directly influence investigators, vendors, external partners, and country managers to deliver these commitments within specified timelines and budgets, with minimal oversight from the line manager.
- Skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment and submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.
- Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding of the 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
Behavioral Competency Expectations
- Problem solving and Process Improvement is essential to this position.
- Ability to pro actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable.
- Strong communication and leadership skills.
- Strong negotiation skills as well as 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 is essential.
- Ability to work effectively also in a remote virtual environment with a wide range of people and 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 of experience 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
Additional Information
- Employee Status: Regular
- Flexible Work Arrangements: Hybrid
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