Job Summary

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

Regular