|Principal Clinical Data Manager|
Company: Johnson & Johnson
Location: Titusville, NJ
Employment Type: Full Time
Date Posted: 07/31/2021
Expire Date: 12/15/2021
Job Categories: Biotechnology and Pharmaceutical, Computers, Software, Healthcare, Other, Healthcare, Practitioner and Technician, Information Technology, Science, Executive Management, Research & Development, Medical, Writing/Authoring
Principal Clinical Data Manager|
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for Principal Clinical Data Manager to be located in Spring House, PA; Raritan, NJ; Titusville, NJ in the US or High Wycombe in the UK or Beerse, Belgium or Basel, Switzerland. There is a possibility of Remote working for exceptional candidates in Europe or North America.
At 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 are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
As a Principal Clinical Data Manager (CDM), you are the data management expert who, within the oncology therapeutic area, is performing scientific complex clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). The CDM is a key contact between the SRP and SRS and the other data management functions, as such supporting flawless data management execution. This position leads or leads others in recognizing opportunities to strengthen the clinical relationship and to further improve the CDM processes.
You will provide support for the SRPs and SRSs of the program you are assigned to. Tapping in to your technical and clinical expertise you will collaborate with the SRP, SRS and the study team members when implementing the data management related activities for protocols, with focus on the more complex indication and therapy related elements of the study. As such, you will review all necessary data flows, the Data Management Plans and perform continuous complex data review activities on the studies in your program.
This position requires strong scientific knowledge in the oncology area and expert knowledge of data management aspects of study protocols. This position requires expert knowledge in current clinical drug development processes, applicable international guidelines and the Janssen's specific interpretation of guidelines regarding data management of clinical trials. Relevant system/technical knowledge is needed. The Principal CDM must have knowledge of current industry standards such as CDISC, SDTM and CDASH. In depth knowledge of the oncology therapeutic area, project management techniques and team management principles are required. Knowledge of technology platforms and systems to capture and process data as well as understanding of data privacy rules in relation to clinical data exchange is needed.
The Principal CDM will work independently, and work is reviewed during major deliverables and completed in collaboration with the Data Management Leaders, the DM TA Head and the Data Management Operations Head, or with Data Management Infrastructure Organization.
The Principal CDM will have no direct reports and will coaches CDMs, Senior CDMs and CDM Specialists. on compound level responsibilities and may delegate work to CDMs, Senior CDMs, and Specialist CDMs.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability
United States-Pennsylvania-Spring House-Welsh & McKean Roads
North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Switzerland-Basel-Country, United States-New Jersey-Titusville, United Kingdom-England-High Wycombe
Janssen Research & Development, LLC (6084)