Clinical Operations Manager FSP📣 إعلان

About the Role

Thermo Fisher Scientific, Inc. is seeking a Clinical Operations Manager for its FSP (Functional Service Provider) division in Saudi Arabia. This full-time position involves overseeing clinical operations teams to support pharmaceutical and biotechnology companies in managing global clinical trials.

Role Overview and Responsibilities

The Clinical Operations Manager will be responsible for the direct management of clinical operations staff. This includes providing oversight, training, resource allocation, coaching, and performance management to ensure the achievement of end results measured by key performance indicators. The role serves as a point of escalation for performance and training concerns, ensuring adherence to company Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs). Collaboration with the leadership team for resourcing needs is also a critical component of this position.

• Manage staff, providing coaching, mentorship, and work direction.
• Conduct regular performance appraisals and career discussions to facilitate employee development.
• Oversee the recruitment, interview, and selection process for new staff.
• Manage and conduct induction and orientation programs for new employees.
• Ensure all staff CVs, training records, position profiles, and experience profiles are complete and current.
• Monitor and ensure the timeliness and accuracy of timesheets and expense reports.
• Support staff allocation activities according to local resourcing processes and optimize project operations.
• Identify and raise any issues that may impact project deliverables.
• Deliver training on Working Practice Documents (WPDs), Standard Operating Procedures (SOPs), local requirements, and other relevant clinical operations topics.
• Identify training gaps and ensure all training requirements are met.
• Assure adherence to good ethical and regulatory standards.
• Alert management to quality issues, request QA audits, and facilitate client and internal quality assurance audits.
• Review systems (*, Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs, and overall project status.
• Evaluate staff work, including conducting PAVs (remote or on-site) to assess monitoring skills and project execution.
• Participate in process improvement and development initiatives.
• Ensure understanding and facilitation of the risk-based monitoring approach.
• Provide input into bids and contribute to business development efforts.
• Collaborate with senior management on strategic planning and business development.
• Lead or contribute to initiatives aimed at enhancing department performance or driving process improvements across the company.

Qualifications and Experience

Candidates should possess the knowledge, skills, and abilities required for the role, typically equivalent to 5 or more years of relevant experience. A minimum of 1 year of leadership responsibility is required, along with advanced mentoring, leadership, and supervisory skills. Demonstrated excellent clinical trials monitoring skills, both remote and on-site, are essential. Candidates must have a demonstrated understanding of, or the ability to quickly learn, the company’s SOPs, WPDs, and relevant regulations such as ICH/GCP and FDA guidelines. The ability to evaluate medical research data is also required.

• 5+ years of relevant experience.
• 1+ year of leadership responsibility.
• Advanced mentoring/leadership/supervisory skills.
• Excellent clinical trials monitoring skills (Remote and on-site).
• Demonstrated understanding of or ability to learn company SOPs, WPDs, and relevant regulations (*, ICH/GCP, FDA guidelines).
• Demonstrated ability to evaluate medical research data.
• Solid knowledge of medical/therapeutic areas and medical terminology.

Required Skills and Competencies

Strong organizational and negotiation skills are necessary, as is a high level of attention to detail. Advanced written and oral communication skills are required. Fluency in Arabic and a very good command of English language and grammar are essential for this role. Candidates must demonstrate proficiency in using computers for data entry, archival, and retrieval. The ability to travel as needed is also a requirement.

• Strong organizational and negotiation skills.
• Strong attention to detail.
• Advanced written and oral communication skills.
• Fluency in Arabic and very good knowledge of English language and grammar.
• Demonstrated use of computer for data entry, archival, and retrieval.
• Ability to travel as needed.
• Excellent teammate with team building skills.
• Excellent interpersonal and conflict resolution skills.
• Advanced ability to utilize problem-solving techniques applicable to a constantly changing environment.

Work Type and Considerations

This is a full-time position. In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.