Responsible for the strategic and tactical operational planning and execution of R&D sponsored clinical programs for all corporate sponsored programs for Phase I - Phase IV.
Main Tasks:
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Responsible and accountable for planning, coordinating, overseeing, and conducting complex global clinical trials in one or more therapeutic areas.
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Collaborate in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services.
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Accountable to plan, drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations.
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Lead (multiple) cross-functional teams and drive oversight of CRO’s and vendor management and has in-depth business knowledge and strategic understanding of how cross-functional teams jointly achieve objectives and goals of trial team, utilizing knowledge of the organization, processes, customers, and key business drivers to increase effectiveness.
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Understand the different requirements of agencies related to the clinical packages and plans manages accordingly the different functions (i.e. CSR, TFLs, ISS etc.)
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Responsible for inspection readiness.
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Accountable for CAPAS related to clinical programs within the field of Clinical Operations.
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Accountable and responsible for the financial planning, budget, accruals, forecasts contribution.
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Preparing clinical program updates and/or contribution to them as needed.
Qualification profile:
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Advance degree in life sciences (graduate degree), e.g. Biology, Chemistry, Pharmaceuticals preferred or medical background
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At least 7 years’ experience in clinical research in industry, and at least 5 years in clinical trial management
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Understanding GxP and global requirements
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Strong project management skillsets
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Excellent communication skills and ability to manage cross functional teams
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Ability to deal with complex situations and drive solution orientated thinking
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Fluent in English
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Excellent team player, ability to work under high pressure and pronounced resiliency
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Experience working in an international and cross-functional team
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Ability to present and defend the perspective
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Experienced in Microsoft project, Excel, Power point
Other Tasks:
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Participate in relevant meetings
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Plan and set up cross-functional meetings, meetings with vendors and others as needed
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Own and/or contribute to SOP development /reviews
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Support sponsor oversight through participation in site visits, including Site Initiation Visits (SIVs) and Co-Monitoring Visits, as required