Clinical Operations Manager FSP - Saudi Arabia

Position Overview

We are seeking a highly motivated and experienced Clinical Operations Manager FSP to join our dynamic team in Saudi Arabia. As a key member of our organization, you will play a pivotal role in overseeing, training, and managing a team of clinical operations professionals, driving performance excellence, and ensuring adherence to regulatory and ethical standards. With a proven track record of supporting over 750 biotech and top 50 pharmaceutical companies across 2,700 clinical trials in 100+ countries, this role offers a unique opportunity to contribute to groundbreaking innovations in the healthcare industry.

Key Responsibilities

As a Clinical Operations Manager, your core responsibilities will include:

• Team Leadership and Development: Oversee, mentor, and coach a team of clinical operations staff, providing clear direction and performance management. Conduct regular performance appraisals, career development discussions, and facilitate employee growth through targeted training and development initiatives.
• Recruitment and Onboarding: Lead the recruitment process, including interviewing, selecting, and onboarding new employees. Design and implement comprehensive induction programs to ensure seamless integration into the company culture and operational workflows.
• Compliance and Quality Assurance: Ensure strict adherence to Standard Operating Procedures (SOPs), Working Practice Documents (WPDs), and regulatory guidelines such as ICH/GCP and FDA standards. Monitor quality issues, escalate concerns, and coordinate internal and external quality assurance audits as required.
• Resource and Project Management: Collaborate with leadership teams to address resourcing needs and support allocation activities in alignment with local processes. Work closely with project and functional leads to optimize operational efficiency and mitigate risks that may impact project deliverables.
• Training and Process Improvement: Deliver training on SOPs, WPDs, and other critical clinical operations topics. Identify training gaps, ensure compliance with training requirements, and contribute to the development of training programs. Participate in process improvement initiatives to enhance departmental performance and operational excellence.
• Data Management and Reporting: Utilize clinical trial management systems (e.g., Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, key performance indicators (KPIs), and overall project status. Conduct thorough evaluations, including remote or on-site performance assessments, to ensure high standards of employee performance and project execution.
• Strategic Collaboration: Engage with senior management and executive staff to contribute to strategic planning, business development, and procurement initiatives. Provide input into bids and proposals to support the acquisition of new business opportunities.
• Risk-Based Monitoring: Ensure a comprehensive understanding and implementation of risk-based monitoring approaches to enhance the efficiency and effectiveness of clinical trials.

Qualifications and Skills

To excel in this role, candidates must meet the following requirements:

• Education and Experience: A minimum of 5+ years of relevant experience in clinical operations, with at least 1 year in a leadership or supervisory capacity. Equivalent combinations of education, training, and experience may be considered.
• Regulatory Knowledge: Demonstrated understanding of or ability to learn company SOPs, WPDs, and relevant regulations, including ICH/GCP and FDA guidelines.
• Leadership and Mentoring: Advanced mentoring, leadership, and supervisory skills with a proven ability to develop and motivate teams.
• Technical Proficiency: Strong organizational, negotiation, and attention to detail skills. Proficiency in data entry, archival, and retrieval using clinical trial management systems. Ability to travel as needed to support operational requirements.
• Communication: Excellent written and oral communication skills in both Arabic and English, with a strong command of the English language and grammar.
• Ethical and Professional Standards: Commitment to maintaining the highest ethical and professional standards in all clinical operations activities.

Why Join Us?

By joining our team, you will become part of a global organization dedicated to advancing healthcare through innovation and excellence. You will have the opportunity to work on cutting-edge clinical trials, collaborate with industry leaders, and contribute to meaningful advancements in patient care. We offer a competitive compensation package, professional development opportunities, and a collaborative work environment that values your expertise and growth.