Jobbeschreibung

Positionsnummer / Reference Number

TA1200302032021

Position / Job Title

Clinical Operations Manager

Aufgaben / Tasks

• Leads or supports cross-functional clinical study teams from start-up through close-out
• Provides or participates in time and cost estimation for clinical study
• Leads or attends bid defense meetings and participates in CRO and/or other vendor selection
• Oversees or supports timely and efficient data entry, data cleaning, interim data cuts and database lock
• Ensures documentation for HA and IRB/EC submissions is available and complete for timely submissions
• Oversees the review and approval of site monitoring reports for all or assigned countries. Ensures follow-up items are being closed out in a timely manner
• Ensure TMF for all or assigned countries is maintained, monitored and closed out on a timely basis
• Liaises with Clinical Supply Chain Lead to ensure forecasting of clinical and non-clinical supplies accurately reflects trial needs
• Reviews and input to clinical documents, such as study protocol, informed consent, investigator brochure, regulatory updates, study manuals
• Manages CRO/vendor selection, set-up, conduct and close-out for all or assigned vendors or vendor tasks, as appropriate
• Ensures or supports that clinical study is delivered on time, on budget and to quality standards
• Oversees investigator payments for European sites, as appropriate
• Ensures or supports that vendors (e.g. CRO) effectively provide service within contracted time and budget
• Oversees invoice reconciliation, scoping, and change orders for all or assigned vendors
• Provides input to finance on budget accruals and forecasts, according to clinical trial budgeting process
• Exhibits a strong understanding of clinical study goals and program objectives and an ability to assess key performance indicators
• Ensures or supports the achievement of performance goals; reports on study performance
• Leads or supports risk assessment, risk mitigation, risk monitoring and issue resolution throughout the clinical study and ensures all necessary functions are informed
• Ensures inspection readiness

Supervisory Responsibilities:
• Mentors more junior study team members by delegating responsibilities, whilst overseeing and providing support with assigned tasks, in line with their development plans
• Provides constructive feedback on study team members to their line managers to support performance review
• May line manage associate roles

Qualifikationen / Qualifications

•Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline
•Minimum of 5 years of experience in clinical operations
•Indication specific expertise within oncology
•Excellent communication and organizational skills
•Business fluent in English

Weitere Informationen / Further Information

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