Clinical Project Manager-230003CJ
**Applicants are required to read, write, and speak the following languages***: English, Spanish
**Preferred Qualifications**
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 integral 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.
KEY OUTCOMES
Management, maintenance and coordination of the logístical aspects of clinical trials and non-interventional studies (NIS) according to GCP/GPP and relevant SOPs, supporting the Senior Project Manager
Act as contact person for routine study related issues for the Cerner Enviza study team(s) and at Cerner Enviza affiliates, the investigative sites as well as for the sponsor and possible further external suppliers (e.g. central lab, translation services)
Act as central project manager for clinical trials and non-interventional studies
May act as local project manager for clinical trials and non-interventional studies in European countries (including feasibility, site contracting, remuneration among other tasks)
Accountable for achieving successful delivery of services at the project level by meeting company and regulatory requirements, quality/scope, timelines and budget constraints
Support set-up and coordination of monitoring-related activities. May act as a Co-Monitor for monitoring activities in European countries
Coordinate regulatory and ethical aspects needed for initiating multinational studies globally and if required, perform regulatory and ethical tasks in the European countries
Ensure that the conduct of the study complies with the currently approved protocol/amendment(s), GCP/GPP guidelines, and all applicable regulatory requirements
Support proposal and budget preparation and preparation of client presentation (e.g. bid defense meeting)
Qualifications:
Bachelor´s Degree in Life Sciences, Pharmacy or Public Health or relevant professional education with several of practical experience. An epidemiological background will be highly recognized
Clinical project management experience (or similar research experience) with increasing levels of responsibility, ideally within CRO industry. Experience in the pharmaceutical, biotechnology or medical device industry could be beneficent
Well experienced in regulatory and ethical requirements for clinical trials and non-interventional studies (NIS)
Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods
Experience in late phase/non-interventional research
Knowledge of regulatory and ethical approaches in the European countries
Excellent verbal and written communication skills in English and Spanish
Very good knowledge of MS Office
**Detailed Description and Job Requirements**
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
**Job**: Consulting
**Location**: ES-ES,Spain-Madrid
**Job Type**: Regular Employee Hire
**Organization**: Oracle