Senior Clinical Data Manager (1 of 3)
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for Senior Clinical Data Manager. This position can be located in Spring House, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium; Leiden, Netherlands; Breda, Netherlands; High Wycombe, United Kingdom; or Allschwil (Basel), Switzerland. Remote locations within North America and Europe may be considered.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.
The Senior Clinical Data Manager (CDM) 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 ensure flawless data management execution. This position will identify and participate in process, system and tool improvement initiatives within Data Management (DM).
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.
- 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 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 follow‐up regularly to ensure delivery of all relevant Data Management milestones.
- Review complex scientific clinical study data, manage CDM and SRP/SRS related queries in the Electronic Data Capture (EDC) system and collaborate with SRS/SRP. Involvement in other review activities (e.g. Coding, Serious Adverse Event (SAE) reconciliation).
- Lead and/or attend meetings, as appropriate.
- Create the 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 Johnson & Johnson internal audits as necessary.
- Plan and track applicable CDM deliverables. Ensure CDM deliverables are on time.
- 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.
- 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), 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.
- 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 will require up to 10% travel.
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.Primary Location
United States-Pennsylvania-Spring House-Welsh & McKean RoadsOther Locations
Europe/Middle East/Africa-Switzerland-Basel-City-Basel, Europe/Middle East/Africa-Netherlands-North Brabant-Breda, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High WycombeOrganization
Janssen Research & Development, LLC (6084)Job Function
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