Grifols Shared Services North America, Inc Clinical Operations Manager in Barcelona, Spain
Grifols is a global healthcare company whose mission is to improve the health and well-being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
WHO WE ARE
Grifols is a global healthcare company with more than 75 years of history improving the health and well-being of people around the world. We produce essential plasma medicines for patients and provide hospitals, pharmacies, and healthcare professionals with tools, information, and services they need to efficiently deliver expert medical care. We are present in more than 100 countries, with global headquarters in Barcelona, Spain, where the company was founded.
As a company committed to serving people, we seek to hire and retain the very best employees.
Our day-today corporate culture reflects the Grifols Spirit, which is defined by our Values.
From Clinical Development department we are looking for a Clinical Operations Manager for the oversight and coordination of execution of clinical trials, for licensure of new products or lifecycle modifications of currently licensed products, with high quality and meeting the Standard Operational Procedures (SOP), Good Clinical Practices (GCP)/International Conference on Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH) and all applicable regulatory requirements.
YOUR TASK AND RESPONSABILITIES
Operational coordination relative to the direction, planning, execution, and interpretation of clinical programs to get documentation to support licensure of new products or lifecycle modifications of currently licensed products:
Supervises coordination of Clinical Operations with Medical and Technical, Global Drug Safety, Legal, Clinical Trial Supplies, and Regulatory to facilitate clinical programs and ensure operational excellence.
Partners with Medical and Technical to troubleshoot study conduct issues and provide direction for clinical responses to questions from investigators, site coordinators, health authorities and institutional review boards.
Maintains wide management of human resources:
Coordinates a multidisciplinary organization that includes Program Leader, Program Manager, Clinical Research Associate and Clinical Trial Assistant functions which may result into a large network of internal and outsourced human resources.
Ensures that clinical programs are properly resourced, managed and executed within budget and in accordance with established timelines.
Supervises internal staffing and performance management, including performance reviews.
Coordinates updates to the senior management.
Holds accountability for quality, GCP, and ICH aspects of trial execution, evaluation, and interpretation through to final archival to ensure integrity of clinical data and to be in line with regulatory requirements for global submissions:
- Ensures compliance with SOPs and GCP/ICH and regulatory guidelines.
WHO YOU ARE
Life sciences degree
A minimum of 5 years of experience in clinical study execution and 3 years’ experience in clinical project management.
Experience managing complex projects and across global regions desirable.
Experience Clinical Quality Assurance is a plus.
Demonstrated leadership of cross-functional project teams and an ability to drive project plans to completion.
Excellent interpersonal, organization, communication and influencing skills, able to work with internal and external stakeholders.
Good team player with global mindset.
Ability to work independently and with rigor.
Advanced knowledge of ICH/GCP and relevant regulations for the conduct of clinical trials.
Good acknowledge of Microsoft Office
Advanced/C1 level of English
WHAT WE OFFER
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets.
We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working
Information about Grifols is available at www.grifols.com at http://www.grifols.com/
If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply!
We look forward to receiving your application!
Grifols is an equal opportunity employer.
Contract of employment: temporary position
Location: Sant Cugat, Barcelona, Spain
Learn more about Grifols at http://www.grifols.com/es/web/international/home