​​​​​ Cerner Enviza (an Oracle company) is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research.

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine,    there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.

Cerner Enviza are looking for a One Year Maternity Cover Regulatory & Safety Project Manager for Real World Evidence and non-interventional studies. This role is a remote role to be based in Spain.

The Regulatory & Safety Project Manager will be primarily responsible for the daily tasks associated with the project management of regulatory engagements which includes accuracy of survey programming for content, skip logic, data checking, managing third party vendors and checking the work they produce, opening POs and invoices. They will be the central contact for routine study related issues, participation in creation of study documents, preparation of documents for submission and notification process, administration of invoices, may assist in monitoring tasks. The Regulatory & Safety Project Manager will overtake the main responsibility for a successful management of the submission and notification process in the countries participating in each study and for negotiation of contracts (sites, vendors etc.)

The successful candidate should have a Master´s Degree (or similar qualification) in Life Sciences, Pharmacy or Public Health or relevant professional education with an additional 3 years (minimum) of practical experience in RWE, regulatory and/or non-interventional studies focused on medicinal products and medical devices, preferably in a CRO(s). An epidemiological background will be highly recognized.

Responsible for conducting applied research in scientific area of focus. Investigating applicable solutions through rigorous, protracted studies and ensuring that a quality, integrated solution is delivered in a timely manner, at budget, and to our client*s satisfaction. This involves working closely with the client to understand and manage their expectations, as well as working closely with Oracle and third-party vendors to ensure delivery.

Entry-level position for those who are new to consulting and are developing their expertise. Receives detailed instruction on routine work and is responsible for performing basic experiments and test on research topic and documenting results. As a member of a project team, follows standard practices and procedures to evaluate and analyze data, develop reports and presentations in external customer engagements. Uses available tools to analyze and solve problems for clients. May perform other duties as assigned.

Bachelors or Advanced degree in a discipline relevant to area of focus, plus 1 year related work experience. Minimum Qualifications: At least 4 years Total combined related work experience and completed higher education. Depending on the job there may be additional minimum requirements and/or preferred qualifications