شركة MSD Gulf تعلن عن وظيفة مدير العمليات السريرية في الرياض
Clinical Operations Manager
🏢 MSD Gulf
تفاصيل الوظيفة
مدير العمليات السريرية - شركة MSD Gulf - منطقة الرياض
المهام والمسؤوليات
- الإشراف على تنفيذ الأنشطة السريرية المحلية للتجارب السريرية وفقاً لمعايير ICH/GCP واللوائح المحلية وسياسات الشركة ومعايير الجودة الداخلية والخارجية.
- تحمل مسؤولية الامتثال التنظيمي والمالي المحلي، وقيادة التأثير المباشر وغير المباشر على الباحثين والموردين والشركاء الخارجيين ومديري الدول لتحقيق الالتزامات ضمن الميزانيات والجداول الزمنية المحددة.
- إدارة مفاوضات الميزانية والعقود، والإلمام بالبيئة الأخلاقية والتشريعية والتنظيمية المحلية وعمليات التقديم والموافقة، وتطوير نموذج الموافقة المستنيرة المحلي ومستندات الدراسة الأخرى.
- وضع خطط إدارة المخاطر والتخفيف منها في الدولة وحل المشكلات محلياً، واتخاذ القرارات المستقلة مع فهم واضح لإيجابيات وسلبيات كل قرار.
- الإشراف على إدارة المشاريع السريرية والتنسيق بين الفرق، والعمل على تحسين العمليات وحل المشكلات من خلال تحديد المخاطر وتحليل السبب الجذري واقتراح الحلول المناسبة.
- إدارة فرق العمل (عبر الدول) والتواصل بفعالية في بيئة عمل افتراضية مع فهم الاختلافات الثقافية.
الشروط والمتطلبات
- خبرة لا تقل عن 10 سنوات في مجال البحث السريري، منها 7 سنوات على الأقل في أنشطة بدء الدراسات في المملكة العربية السعودية.
- يفضل خبرة إضافية في بدء الدراسات في دول الشرق الأوسط الأخرى.
- درجة البكالوريوس (أو ما يعادلها) في إدارة الأعمال/المالية/العلوم الحياتية أو مجال صحي ذي صلة.
- يفضل درجة الماجستير (أو شهادة معادلة) في إدارة الأعمال/المالية/العلوم الحياتية/إدارة المشاريع.
- إتقان اللغتين الإنجليزية والعربية.
المهارات المطلوبة
- إعداد الميزانيات والامتثال للتجارب السريرية وتوثيقها وإدارتها ومراقبتها وعملياتها.
- مهارات التواصل والتفاوض والتأثير والإرشاد (كتابياً وشفهياً).
- فهم وممارسة إرشادات ICH GCP.
- إدارة العقود والامتثال التنظيمي.
- مهارات القيادة وإدارة الأولويات المتعددة والعمل في بيئة افتراضية.
عرض النص الأصلي للإعلان
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
Required
Required
Preferred
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
Preferred Skills
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
06/22/2026
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
- 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. Specific examples of common problems include 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverablesthat could jeopardize protocol milestones.
- 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
Required
- 10 years of experience in clinical research with at least 7 years of experience in Startup activities in Saudi Arabia.
- Additional Startup Experience in other Middle East Countries.
Required
- Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or
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
Preferred Skills
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
06/22/2026
- A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
المصدر: LinkedIn - أُضيفت للموقع في 15 يونيو 2026