Clinical Operations Manager – FSP
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Job Description
Clinical Operations Manager overseeing clinical operations and team performance for a global scientific leader. Collaborating with senior management and ensuring compliance with industry standards.
Responsibilities:
- 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.
- Raises appropriately any issues which may impact project deliverables.
- Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations.
- Identifies training gaps and ensures that training requirements are met.
- May contribute to development of training programs, where appropriate.
- Assures adherence to good ethical and regulatory standards.
- Alerts management to quality issues, requests QA audits as appropriate, and facilitates 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 employee monitoring skills and project conduction when applicable.
- Participates in process improvement/development initiatives.
- Ensures understanding and facilitation of the risk-based monitoring approach.
- May provide input into bids and contribute to the procurement of new business where required.
- Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required.
- May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.
Requirements:
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- 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 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
- Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
- Solid knowledge of medical/therapeutic areas and medical terminology
Benefits:
- Flexible work arrangements
- Professional development
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