Principal Clinical Data Manager ( 1 of 5)
- Titusville, NJ
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Principal Clinical Data Manager located in Spring House, PA; Raritan, NJ; Titusville, NJ; United Kingdom or Beerse, Belgium.
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.
- Shapes and drives indication/compound aspects of the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Reviews related clinical data management documents. Ensures compliance with regulatory guidelines and documentation requirements. CDM will be involved in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
- CDM reviews complex scientific clinical study data, manages CDM and SRP/SRS related queries in eDC system and collaborates closely with SRP/SRS . Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible. CDM will lead and/or attend meetings, as appropriate
- Takes a leadership role with SRP/SRS to establish, align and confirms complex scientific clinical data review expectations at the compound and or TA level.
- With the SRP/SRS, CRO and other functional partners in relation to CDM related activities:
- Oversees the gathering of content for eCRF and other data
collection tools within a program.
- Leads conventions and quality expectations for clinical data.
- Ensures timelines are established and that follow-up occurs regularly to ensure delivery of all
relevant clinical data management milestones.
- Identifies and communicates ways to improve expectations.
- Leads the setting of expectations and review for dataset content and structure over trials within a program.
- Ensures that CDM documents are reviewed accurately to facilitate appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency at the program level. Ensures compliance with regulatory guidelines and the documentation matrix at the program level.
- Oversees the assessment of real-time inspection readiness of all DM deliverables for the trials within a program.
- Oversees and guides the planning and tracking of clinical data content, format, quality, and timing of CDM deliverables.
- Oversees the monitoring and tracking of clinical data deliverables.
- Collaborates with the DML and the DM TA Head to distribute work assignments and identify needed
- Collaborates with enabling technology organization to ensure that CDM tools and systems are deployed on time and with quality
- Takes a leadership role to obtain, share, and develop best practices with internal and external
partners. Leads or leads others (depending on the complexity or scope of the project) in developing and implementing process, system, and tool improvement
initiatives within CDM role.
- Functional contacts within the Integrated Data Analytics & Reporting department include, but are not limited to DM TA Head, Data Management Leaders (DML), Global Data Managers (GDM), Data Acquisition Experts and Clinical Programmers, , Statistical Programmers, Clinical Data Standards, Risk Management Central Monitoring associates, Regulatory Medical Writing associates and Coders.
- Functional contacts in Janssen (as collaborator) include but are not limited to Study Responsible Physicians, Study Responsible Scientists, Global Development Trial Leader and Biostatisticians.
- External contacts include but are not limited to, external technology partners and vendor liaisons.
- MS degree or PhD in Science or BS/BA degree in Science with professional experience equivalent
- A minimum of 7 years of Data Management experience specifically data review including patient profile experience, clinical data review and knowledge of medical terminology
- Experience in clinical drug development within the pharmaceutical industry or CRO
- Team leadership experience
- Project management experience
- Collaboration with Clinical teams
- Strong scientific knowledge (educational/professional) and 5+ years experience in the oncology therapeutic area
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-
Europe/Middle East/Africa-United Kingdom-England, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Research & Development, LLC (6084)
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