Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for Clinical Data Manager Specialist (CDM), 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.
The Clinical Data Manager (CDM) Specialist will be the data management expert within the Oncology Therapeutic Area and will perform scientific complex clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). This individual will be a key contact between the SRP and SRS and the other data management functions in order to support flawless data management execution. This position will contribute or take a lead in recognizing opportunities to strengthen the clinical relationship and to further improve the CDM processes.
The CDM will provide support for the SRPs and SRSs of the program you are assigned to. Tapping into technical and clinical expertise, 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. Review all necessary data flows, the Data Management Plans and perform continuous complex data review activities on the studies in your program.
The CDM Specialist will work independently, and work will be reviewed with the Data Management Leaders (DML) or the immediate manager as needed during major deliverables as needed. This individual will have no direct reports but will coach CDMs and Senior CDMs on trial level responsibilities. In addition, may delegate work to CDMs and Senior CDMs.
Involvement in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
Take a leadership role with SRP/SRS to establish, align and confirm complex scientific clinical data review expectations for assigned trial(s).
With the SRP/SRS, CRO and other functional partners in relation to CDM related activities:
Review content for Electronic Code of Federal Regulations (eCRF) and other data collection tools.
Establish conventions and quality expectations for clinical data.
Set timelines and followup regularly to ensure delivery of all relevant Data Management milestones.
Identify and communicate ways to improve deliverables.
Review complex scientific clinical study data, manages CDM and SRP/SRS related queries in Electronic Data Capture (EDC) system and collaborate with SRP/SRS. Involvement in other review activities (e.g., Coding, Serious Adverse Event (SAE) reconciliation).
Lead and/or attend meetings, as appropriate.
Create the trial level or disease area Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Review related clinical data management documents. Ensure compliance with regulatory guidelines and documentation requirements.
Ensure realtime inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and J&J internal audits as necessary.
Identify and communicate lessons learned, best practices and frequently asked questions at the
Identify and participate in process, system, and tool improvement initiatives within Data Management.
Lead or participate, depending on the complexity of the project, in implementing process, system, and tool improvement initiatives within CDM.
A minimum of a Bachelor's degree in a Scientific discipline
A minimum of 5 years of experience in data management (specifically in clinical data review), or significant experience with clinical data review
Strong scientific knowledge (educational/professional)
Experience in clinical drug development within the Pharmaceutical industry, Contract Research Organization or related industry
Knowledge of medical terminology
Must have excellent verbal and written communication skills.
Must have the ability to adapt to a rapidly changing organization and business environment.
The ability to collaborate with clinical teams and all levels of management across a matrix environment
This position will require up to 10% travel.
Advanced degree (Master's, PhD) in a Scientific discipline
Experience in the Oncology Therapeutic Areas
Knowledge of current industry standards (i.e., CDISC, SDTM, CDASH)
Team leadership experience
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-Switzerland-Basel-City, United Kingdom-England-High Wycombe, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Research & Development, LLC (6084)
Johnson & Johnson