Clinical Data Reviewer
We are currently recruiting for a Clinical Data Reviewer (CDR) to work office-based with one of the largest and most successful Pharmaceutical companies in the world. Employment would come from inVentiv Health and you would be outsourced to this client. Working on mainly oncology studies you will work closely with the CDR team in the USA and the Clinical Scientist team in Europe providing expertise with data review.
The Clinical Data Reviewer (CDR) supports various studies, most often in a submission timeline, by assisting study teams with their data review. The studies supported by the CDR are often phase 3 pivotal trials that are high-enrolling and require robust data capture.
A CDR works in conjunction with each study team to support existing data review requirements and tasks will include:
* Reviewing tasks performed by a CDR including both point-to-point checks relating to study inclusion criteria
* Interpretive analysis relating to inconsistencies in the patient profile data
* In-depth understanding of the therapeutic area (oncology) under investigation and the investigational drug and supportive medications and raising/escalating erroneous or illogical data
* Perform data review tasks on a full-time basis
To be eligible for this role you must have worked within Clinical Data Review within the Pharmaceutical industry, hold an EU passport or valid working visa for Poland and speak fluent English.
Additional requirements include:
* Bachelor's degree or equivalent in one of the disciplines related to life sciences, drug development or business.
* Advanced degree is desirable.
* Previous experience in clinical operations in pharmaceutical industry in order to have a thorough understanding of the processes associated with delivery of quality data.
* Expertise in conduct of clinical trials in Oncology
* Experience in the review of clinical study data
* Comfortable working with large data sets
* Familiar with Oracle Clinical Remote Data Capture
* Technically competent with Microsoft Excel
* Possesses rudimentary knowledge of data management including case report form design, workings of electronic edit checks, implementation of data handling conventions and interpretation of data status reports
* Able to work independently for periods of several days without much supervisory contact
There are many benefits available to employees of inVentiv. They include competitive compensation and benefits (details on request).
If you have the required experience for this position and are eligible to work in the required location then please apply by CV or contact Magdalena Raczyńska on
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You'll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.