Senior Manager Clinical Operations (m/f/d)

Fresenius; Barcelona; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Fresenius SE & Co. KGaA in Spain and Hungary seeks a senior Clinical Operations leader to plan and execute global clinical programs (Phase I–IV).

You will oversee trials, coordinate cross-functional teams, CROs and vendors, and ensure delivery on scope, timelines and budget. Advanced life sciences degree and 7+ years in clinical research plus 5+ years in trial management are required, with strong GxP knowledge and excellent English.

Qualifications

• 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

Responsabilités

• 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.

Connaissances

Project management

Cross-functional leadership

Communication

Budgeting / financial planning

Risk management

GxP knowledge

Formation

Advanced degree in life sciences

Outils

Microsoft Project

Excel

PowerPoint

Description du poste

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