Global Clinical Trial Head/Leader

12/2009 – offen

Serve as Global Clinical Trial Head for Phase I, 1b and II trials and, leads and coordinates two or
more global operational studies
Provide direction and leadership to global operation projects to ensure delivery of all cross
functional activites to meet study plans outlined by the clinical development plan
Be responsible for the preparation of the Clinical Study Protocol, report and publication
Be responsible for the creation and management of stuty timelines, budget, resources,
risk/safety, and quality plans.
Responsible for biomarkers
Contribute to the preparation and update of clinical program documents (IB, IND, ASR, IMPD,
Health Authorities briefing books and submissions) and responses to health authorities questions
Selection of CRO,s and vendors, provide directions and oversight of outsourced activities to
ensure CRO,s and vendors delivery against contarcted scope of work
Lead the clinical trial team and be a member of the international clinical team
Coach and Provide study specific mentoring to CRAs, CTAs and train the team and other study
specific department staff members
Contribute to multidisciplinary task forces to support continuous improvement
Seroius Adverse Events (SAE´s) reconciliation
Contribute to the medical/scientific input given for the development of trial-related documents and
process which reside in order line functions; Obtains approval from internal review boards.
Collaborate with the Medical Directors of the Novartis local organizations (CPOs) to ensure
country feedback is adequately integrated into protocol
Accountable for all clinical meetings related to the clinical trial(s).
Lead the clinical trial data and ongoing medical/scientific review, final analysis and
interpretation including the development of clinical trial reports, publications and
internal/external presentations.

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Responsible for the organisation of real time review of data´s and provide
consolidated infor