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Clinical Operations Manager FSP - UAE

Thermo Fisher Scientific
Dubai, UAE
Full Time
Manager
Onsite
6 days ago
Clinical Trial MonitoringLeadershipMentoringRegulatory Compliance (ICH/GCP)Performance ManagementCTMS
Free

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Clinical Trial MonitoringLeadershipMentoring
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Role Overview

  • We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
  • As a Clinical Operations Manager, you will oversee, train, resource, coach and performance manage a team, which may be inclusive of various clinical operations focused staff.
  • You will focus on end results using metrics and key performance indicators to lead performance.
  • You will act as point of escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs.
  • You will also work in collaboration with the leadership team for resourcing needs.

What You’ll Do

  • Manages staff, providing coaching, mentorship and work direction.
  • Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff.
  • Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.
  • Ensures all staff CVs, training records, position profiles and experience profiles are complete and up to date. Ensures timeliness and accuracy of timesheets and expense reports.
  • Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects.
  • Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations.
  • Assures adherence to good ethical and regulatory standards.
  • Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required.
  • Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
  • Evaluates work of staff, including conducting PAVs (either remote or on site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
  • Participates in process improvement/development initiatives.
  • Ensures understanding and facilitation of the risk based monitoring approach.

Education and Experience Requirements

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
  • 1+ year of leadership responsibility
  • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient.

Knowledge, Skills and Abilities

  • Advanced mentoring/leadership/supervisory skills
  • Excellent clinical trials monitoring skills; Remote and on site
  • Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
  • Demonstrated ability to evaluate medical research data
  • 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 to include data entry, archival and retrieval
  • Ability to travel as needed
  • Excellent teammate with team building skills
  • Excellent interpersonal and conflict resolution skills

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