Job Description

Posting Title: Senior Clinical Data Manager

Janssen Research & Development, LLC, a member of Johnson & Johnson\'s Family of Companies is recruiting for a Senior Clinical Data Manager. This position can be located in Spring House, PA; Raritan, NJ; Titusville, NJ; Shanghai, China; Tokyo, Japan; Beerse, Belgium; Leiden, Netherlands; Mumbai, India; High Wycombe, United Kingdom; or Basel, Switzerland. Remote locations within North America, Asia, and Europe may be considered on a case-by-case basis and if approved by the company.
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 Senior Clinical Data Manager (CDM) will be the data management expert who 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 Senior 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 Senior CDM will work independently and has no direct reports. Work is reviewed on an ongoing basis with the Data Management Leader.

Primary responsibilities:

• 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:

o Review content for Electronic Code of Federal Regulations (eCRF) and other data collection tools.
o Establish conventions and quality expectations for clinical data.
o Set timelines and follow-up regularly to ensure delivery of all relevant Data Management milestones.
o 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 real-time 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
• trial level.
• 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.Qualifications:

• A minimum of a Bachelor\'s degree in a Scientific discipline is required. Advanced degree (Master\'s, PhD) in a Scientific discilpine is preferred.
• A minimum of 3 years of experience in data management (specifically in clinical data review including patient profile experience), or significant experience with clinical data review is required.
• Strong scientific knowledge (educational/professional) is required
• Experience in the Oncology Therapeutic Area is preferred.
• Experience in clinical drug development within the Pharmaceutical industry, Contract Research Organization or related industry is required.
• Knowledge of medical terminology is required.
• Knowledge of current industry standards (i.e., CDISC, SDTM, CDASH) preferred.
• Team leadership experience is preferred.
• 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 is required.
• This position may require up to 10% travel.

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