Location: Spain and Hungary
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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:

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- 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. xhfqzwm

- 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

- At least 7 years’ experience in clinical research in industry, and at least 5 years in clinical trial management

- Understanding GxP and integral 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:

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- 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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📌 Senior Manager Clinical Operations (M/F/D) (Barcelona)
🏢 Fresenius Se Kgaa
📍 Barcelona