Senior Clinical Data Manager

Job title:

Senior Clinical Data Manager

Company

Johnson & Johnson

Job description

A s a Senior C linical D ata M anager (Sr. CDM) , you are the d ata m anagement 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 Sr. CDM is a key contact between the SRP and SRS and the other data management functions as such in order to ensure flawless data management execution. This position identifies and participates in process, system and tool improvement initiatives within DM.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 in-depth knowledge of data management aspects of study protocols. The Sr. CDM must have in-depth knowledge of the clinical drug development process, the applicable international guidelines and Johnson & Johnson Innovative Medicine’s specific interpretation of guidelines regarding data management of clinical trials. 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. This position needs to have knowledge of current industry standards (i.e., CDISC, SDTM, CDASH)The Sr. CDM will work independently and work is reviewed on an ongoing basis with the Data Management Leader. The Sr. CDM will have no direct reports.Principal Responsibilities:

• Sr. 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.

• Takes 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:

o Reviews content for eCRF and other data collection toolso Establishes conventions and quality expectations for clinical data.o Set timelines and follow-up regularly to ensure delivery of all relevant Data Management milestones.

• Sr. CDM reviews complex scientific clinical study data, manages CDM and SRP/SRS related queries in eDC system and collaborates with Study Responsible Physician/Study Responsible Scientist (SRS/SRP). Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible. Sr. CDM will lead and/or attend meetings, as appropriate.

• Creates 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.

• Ensures real-time inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and J&J internal audits as necessary.

• Plans and tracks applicable CDM deliverables. Ensures CDM deliverables are on time.

• Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.

• Identifies and participates in process, system, and tool improvement initiatives within DM.Education and Experience Requirements:

Core Experience:

• MS degree or PhD in Science or BS/BA degree in Science with professional experience equivalent

• Minimum of 3 years Data Management experience, specifically data review including patient profile experience, clinical data review or significant experience with clinical data review knowledge of medical terminology.

• Collaboration with Clinical teams

• Experience in clinical drug development within the pharmaceutical industry or CRO

• Strong scientific knowledge (educational/professional) preferably in the relevant therapeutic area

About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.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.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Expected salary

Location

Beerse, Antwerpen

Job date

Sat, 23 Mar 2024 23:16:06 GMT

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