Senior Manager Clinical Operations (m/f/d)
Fresenius Kabi · Eysins
Location: Spain and Hungary
Functional Goal:
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:
Responsible and accountable for planning, coordinating, overseeing, and conducting complex global clinical trials in one or more therapeutic areas.
Collaborate in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services.
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.
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.
Understand the different requirements of agencies related to the clinical packages and plans manages accordingly the different functions (i.e. CSR, TFLs, ISS etc.)
Responsible for inspection readiness.
Accountable for CAPAS related to clinical programs within the field of Clinical Operations.
Accountable and responsible for the financial planning, budget, accruals, forecasts contribution.
Preparing clinical program updates and/or contribution to them as needed.
Qualification profile:
Advance degree in life sciences (graduate degree), e.g. Biology, Chemistry, Pharmaceuticals preferred or medical background
At least 7 years’ experience in clinical research in industry, and at least 5 years in clinical trial management
Understanding GxP and global requirements
Strong project management skillsets
Excellent communication skills and ability to manage cross functional teams
Ability to deal with complex situations and drive solution orientated thinking
Fluent in English
Excellent team player, ability to work under high pressure and pronounced resiliency
Experience working in an international and cross-functional team
Ability to present and defend the perspective
Experienced in Microsoft project, Excel, Power point
Other Tasks:
Participate in relevant meetings
Plan and set up cross-functional meetings, meetings with vendors and others as needed
Own and/or contribute to SOP development /reviews
Support sponsor oversight through participation in site visits, including Site Initiation Visits (SIVs) and Co-Monitoring Visits, as required
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