Clinical Operations Lead job in Fort Worth
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
The Clinical Operations Lead is responsible for supporting the implementation and execution of Alcon's clinical trials by performing specific project management tasks at the country, regional and site level. This position ensures trial conduct is efficient, with seamless execution, achievement of timelines and study deliverables with quality, and full compliance with international guidelines, local regulations and corporate policies and procedures. |
• Manages 2-3 clinical trials of low to medium complexity in support of one or more projects.
• Leads the site management team responsible for operational activities for study/site activation, conduct, and close-out of clinical trials within CDMA.
• Shows successful implementation and execution of assigned trial(s) in compliance with guidelines, regulations, and procedures.
• Ensures consistency of Alcon's processes and procedures across sites and studies
• Contributes operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template, data validation plan, etc.
• Develops Protocol Monitoring Plan (PMP)
• Follows study metrics using all available tools, systems and information (e.g., CTMS, EDC, CDM reports) to ensure achievement of target study milestones and deliverables
• Coordinates study activities with assigned CSMs, reinforcing compliance with PMP, relevant procedures, and applicable regulations
• Coordinates, prepares, delivers and tracks protocol specific training for site personnel and assigned CSMs.
• Initiates investigational product shipment requests and resupply as well as coordinates reclamation of supplies for sites on assigned trial(s)
• Creates and maintains user account worksheets for provisioning all site personnel and CTT members for assigned trials into required systems (e.g. EDC, IRT, training portals)
• Actively participates on the Clinical Trial Team (CTT), building relationships and serving as liaison among trial team personnel as appropriate
• Facilitates communication between CTT and sites throughout the trial
• Provides progress reports to CTT and upper management routinely.
• Proactively identifies potential/actual issues and risks, escalates to CTT and management as appropriate, and contributes to mitigation.
• Leads/participates in department and cross-functional process improvement initiatives to improve operational efficiencies.• Fluent in verbal and written English communication skills.
• Bachelor's degree in a related field with 5+ years of directly related working experience OR equivalent combination of education and work experience.
• 5+ years of field clinical monitoring, site management (e.g., study coordinator), and/or clinical research experience.
• Strong problem solving skills and team orientation and adaptability.
• Project Management experience preferred but not required.
Alcon is headquartered in Ft. Worth, TX however remote will be considered.
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