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Job Description
Lead the Study Team to deliver global studies productively and maximise market place impact
Requirements
QUALIFICATIONS, TRAINING, PROFESSIONAL MEMBERSHIPS or ACCREDITATIONS
Essential:
Life-sciences degree or appropriate professional qualifications
EXPERIENCE & TRACK RECORD
Essential:
Significant experience in a broad range of clinical operations Proven track record of clinical study delivery in a broad range
Desirable:
Ability to manage Clinical Research Organisations
Responsibilities
1 Deliver Global Clinical Plans (80%)
Responsible for the delivery of Global Clinical trials to meet or exceed performance metrics
Set objectives for study team members (AZ UKMC or Clinical Research Organisation) to deliver agreed global clinical trials
Prepare study budget and report financial progress (via ClinTracc)
Accountable for efficient set up of critical study activities to agreed metrics
Reporting of study progress/action plans/issues to meet internal customer issues
Maximise market place impact of Global Clinical trials
2 Support Generation of Global Clinical Plans (10%)
Act as the principal contact with Global Clinical by understanding the Clinical Plan and lobbying Global Clinical on behalf of AZ UKMC to deliver that Plan when necessary
Provide input to feasibility of Global trials
Provide other operational expertise to Global as required
Provide international study co-ordination for Global studies as required
Maintain key links with Global Clinical to ensure that M& RA has advance knowledge of planned Global trials
3 Lead the Organisation and Improve Productivity (< 5%)
Create and maintain the Study Team environment that supports innovation, challenges the status quo and provides clear role accountability
Work closely with the Local Study Leaders, briefing them appropriately thus ensuring co-ordination of activities for a Brand
Liaise with Clinical Research Regional Manager to ensure performance of individuals within study team
Accountable for study resources being used effectively and efficiently
Generate resource requests for global studies
Generate, monitor and communicate performance metrics to drive delivery and productivity of studies
4. Customer Shaping (< 5%)
Optimise selection of investigators to support the brand
Build and harness relationships with key customers to support the brand
Lead the implementation of activities to maximise market impact of clinical trials
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