AstraZeneca
Director,SiteManagement&Monitoring
“Director, Site Management & Monitoring at AstraZeneca. Skills: Site Management, Monitoring, Clinical studies, ICH-GCP. Deliver clinical studies according to resources, budget, timelines. Comply with AZ Procedural Documents”
What You'll Achieve.
Deliver committed part of studies; Comply with AZ Procedural Documents; Comply with ICH-GCP; Comply with local regulations; Achieve study delivery country level targets; Maintain eTMF Inspection Ready
Industry & Context.
Resolving key issues; Conflict management; Crisis handling
National and international travel
What They're Looking For.
Must Have
Bachelor degree in related discipline, Minimum 5 years of experience, Proven project management experience, Excellent knowledge of spoken and written English, Good ability to learn and adapt to IT systems, Ability for national and international travel
Nice to Have
Line management experience, Very good knowledge of Clinical Study Process, Very good knowledge of international ICH-GCP guidelines, Excellent knowledge of Monitoring Process, Good understanding of Study Drug Handling Process, Good understanding of Data Management Process, Good knowledge of relevant local and international regulations, Good medical knowledge, Ability to learn relevant AZ Therapeutic Areas, Ability to deliver quality according to standards, Ability to champion more efficient methods, Ability to work in environment of remote collaborators, Integrity and high ethical standards, Good resource management skills, Excellent decision-making skills, Good financial management skills, Good conflict management skills, Ability to handle crisis, Good interviewing skills, Good intercultural awareness, Excellent ability to work according to global standards
What You'll Do.
Deliver clinical studies according to resources
Comply with AZ Procedural Documents
Comply with international guidelines ICH-GCP
Comply with relevant local regulations
Line manage dedicated group of staff
Utilize staff resources
Set objectives for staff
Follow up performance of staff
Develop team style and behaviour
Ensure adequate resources for studies
Ensure adequate workload for direct reports
Manage development of direct reports
Manage performance of direct reports
Ensure development plans for direct reports
Ensure training plans for direct reports
Coach direct reports regularly
Plan coaching with external providers
Prepare salary proposals for direct reports
Prepare bonus proposals for direct reports
Contribute to efficient SMM organisation
Contribute to SMM functioning at country level
Contribute to high quality feasibility work
Oversee delivery of SMM study targets
Contribute to quality improvement of study processes
Ensure systems are continuously updated
Ensure completeness of eTMF
Ensure timeliness of eTMF
Maintain eTMF Inspection Ready
Assist in forecasting study timelines
Assist in forecasting study resources
Assist in forecasting study recruitment
Assist in forecasting study materials
Assist in forecasting study drugs
Provide direction on major study commitments
Resolve key issues identified
Support SMM region in initiatives
Support SMM region in activities
Ensure collaboration with local Medical Affairs team
Ensure study activities comply with local policies
Ensure study activities comply with code of ethics
Review SQV reports of direct reports
Review Accompanied site visits
Review co-monitoring visits
Review training visits
Perform accompanied site visits
Support ongoing coaching
Support ongoing development
How You'll Work.
Team & Collaboration
Cross-functional teams; Local Study Teams; Local Medical Affairs team; Remote collaborators
Communication Scope
Presentation skills; Written communication; Verbal communication
Process & Methodology
Project management, Resource planning, Budget management, Timeline management, Objective setting, Performance follow-up, Feasibility work, Study delivery targets, Study processes, Forecasting study timelines, Forecasting study resources, Study commitments, Resolving key issues, Initiatives and activities
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