Role and Responsibilities
Clinical Operations Line Manager / Dedicated Line Manager Role Definition
The DLM is responsible for the direct oversight, performance management, and skills development of Partner employees assigned to a Sponsor and deployed to a specific geographic and/or therapeutic area.
Clinical Operations Line Manager / Dedicated Line Manager Responsibilities
- Recruit, interview, and identify experienced personnel according to the Functional Resourcing Process and timelines.
- Ensure proper onboarding and offboarding of employees, including compliance with initial and ongoing training requirements.
- Attend or facilitate co-visits during onboarding or as needed to assess confidence in performing activities and site visits independently.
- Train and oversee core competencies, ICH-GCP knowledge, and clinical research environment understanding, monitoring, etc.
- Ensure adherence to GCP guidelines, processes, and procedures related to direct reports’ activities and performance.
- Ensure timely response, escalation, and follow-up on items assigned to direct reports by the Sponsor.
- Ensure direct reports provide timely and quality deliverables.
- Perform partner oversight visits to assess CRA performance according to the client’s oversight plan and inform the Sponsor of any quality concerns promptly.
- Ensure appropriate and timely reporting of site monitoring activities by CRAs.
- Conduct regular 1:1 meetings with direct reports to ensure deliverables and timelines are met.
- Ensure compliance of direct reports with timelines and key business metrics defined by the Sponsor.
- Hold at least monthly meetings with Sponsor country management to review the performance of direct reports regarding protocols/sites assigned.
- Communicate and escalate areas of development and training needs.
- Conduct continuous performance reviews and oversee personal development and career planning of direct reports.
- Provide timely feedback to the Sponsor on performance and ensure proper follow-up.
- Review and approve timesheets, expense reports, and time-off requests, overseeing CRA productivity/utilization.
Qualifications
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- Prior clinical trial experience, including at least 1 year in a management/leadership capacity or an equivalent combination of education, training, and experience.
- In-depth knowledge of applicable clinical research regulatory requirements (GCP and ICH guidelines).
- Good leadership skills.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Excellent written and verbal communication skills in Arabic and English.
- Strong organizational and problem-solving skills.
- Effective time management and ability to manage competing priorities.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com