2 days ago

Trial Data Scientist (Clinical Data Manager)

Actelion Pharmaceuticals Ltd

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Trial Data Scientist (Clinical Data Manager)

Trial Data Scientist (Clinical Data Manager)-(17000063)Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for Trial Data Scientist (Clinical Data Manager).As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.Job Responsibilities

* Ensures Clinical Development Data Management (CDDM) activities related to an assigned study adhere to Actelion Standards, applicable regulations
* Meets study timelines in terms of CDDM deliverables
* Ensures data handling consistency within allocated study(ies)
* Leads Data Management activities for assigned study
* Performs data cleaning and review on a study if needed
* Writes all study Data Management study specific documents
* Represents CDDM at Clinical Trial Team (CTT) meetings
* Manages and is accountable for CDDM activities in studies where CDDM is outsourced
* Presents study related topics at CTT, Investigators and Monitors meetings
* Participates in development and review of policies, Standard Operating Procedures (SOPs), and associated documents for CDDM
* Represents CDDM in cross functional working groups related to the system / process

Candidate Requirements

* Recognized degree in life sciences, mathematics, statistics, informatics or related disciplines
* At least 5 years of experience in Pharmaceutical or Biotech industry within Clinical Research and / or Clinical Data Management with good level of functional expertise in Data Management
* Good knowledge of international clinical research regulations and requirements (e.g., InternationalConference on Harmonization, good Clinical Practice (ICH/GCP))
* Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form (CRF) design
* Ability to lead and coordinate the activity of Data Scientist(s) allocated to his/her study
* Excellent organizational and communication skills
* Fluent in written and spoken English

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.

Primary Location



:Clinical Development



Job Type


Job Posting

:Aug 24, 2017