Job Description

The Principal Clinical Data Management & Safety is responsible for managing an international data management team and delivering data management services to clients and project teams related to Non-Interventional Studies.

The Principal is responsible to manage and motivate the team in a spirit of a growth mindset for people. Inspirational and open to a global culture, the Principal acts as a leader within the global RWE/Clinical domain.

The Principal develops and implements data management strategy and organization to increase productivity and quality, while decreasing cycle times and costs. As part of his role, the Principal provides oversight of project-related data management tasks and is part of different governance groups linked to strategic projects and customers. He is, as well, responsible for optimizing the work allocation across the team, and for adapting the activity to any new regulations.

As part of the strategy, the Principal has an innovation mindset when it comes to integrate new technologies in Data Management activities.

Career Level - M3

Responsibilities

Primary Duties + Responsibility:

• Inspire and lead an international Data management team.

• Subject Matter Expert (SME) for external client’s engagement & internal strategic projects. Interact with clients, to provide a high standard of customer service and ensure complete understanding data management / database development and Safety responsibilities.

• Evaluate and monitor resources.

• Increase operational efficiency and costs.

• Oversee the implementation and management of data management systems and evaluate process improvements and innovative methods for clinical data management.

• Oversee projects, actively part of escalation processes and involve in clients’ audits.

• Support the development and implementation of Data Management & Database Development Standard Operating Procedures (SOPs), guidelines, policies, procedures and requirements, and ensure personnel are trained appropriately.

• Represent Data Management in marketing efforts by developing project bid proposals, participating at bid defense meetings or performing client presentations as requested.

Experience & Minimum Requirements:

• A master’s degree in a health-related field preferred.

• Thorough knowledge of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.

• Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies.

• Skilled in use of computer technology, including clinical trial databases and applications and ability to learn new applications.

• Experience in C-DISC requirements

• Demonstrated ability to lead by example and demonstrated skill for technical and supervisory leadership of staff.

• Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a global team environment.

• Computational knowledge and knowledge in HEOR, Market access and secondary data would be a plus.

At Oracle, we don’t just respect differences—we celebrate them. We believe that innovation starts with inclusion and to create the future we need people with diverse backgrounds, perspectives, and abilities. That’s why we’re committed to creating a workplace where all kinds of people can do their best work. It’s when everyone’s voice is heard and valued that we’re inspired to go beyond what’s been done before.

We expressly encourage disabled candidates to apply for this position. Please therefore feel free to voluntarily inform us in your application about any severe disability (degree of disability of at least 50%) or any equal status (degree of disability of at least 30% together with official decision on equality) in accordance with the German SGB IX.

About Us

As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s problems. True innovation starts with diverse perspectives and various abilities and backgrounds.

When everyone’s voice is heard, we’re inspired to go beyond what’s been done before. It’s why we’re committed to expanding our inclusive workforce that promotes diverse insights and perspectives.

We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity.

Oracle careers open the door to global opportunities where work-life balance flourishes. We offer a highly competitive suite of employee benefits designed on the principles of parity and consistency. We put our people first with flexible medical, life insurance and retirement options. We also encourage employees to give back to their communities through our volunteer programs.

We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by calling +1 888 404 2494, option one.

Disclaimer:

Oracle is an Equal Employment Opportunity Employer*. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

* Which includes being a United States Affirmative Action Employer