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As a Clinical Data Manager Specialist (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 contributes or takes a lead in recognizing opportunities to strengthen the clinical relationship and to further improve the CDM processes.
- Ensures real‐time inspection readiness of all assigned deliverables for the trial; participate in
- Regulatory Agency inspection and J&J internal audits as necessary.
- Takes a leadership role with SRP/SRS to establish, align and confirms 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:
- Establishes conventions and quality expectations for clinical data.
- Identifies and communicates ways to improve deliverables.
- 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 (SRP/SRS). Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible. CDM will lead and/or attend meetings, as appropriate.
- CDM Specialist 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.
- Reviews content for eCRF and other data collection tools
- Set timelines and follow‐up regularly to ensure delivery of all relevant Data Management milestones.
- Creates the trial level or disease area 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.
- Collaboration with Clinical teams.
- Experience in clinical drug development within the pharmaceutical industry or CRO
- Team leadership experience.
- Strong scientific knowledge (educational/professional) and 3-5 years experience in the oncology therapeutic area
Qualification & Experience:
- MS degree or PhD in Science or BS/BA degree in Science with professional experience equivalent.
- Minimum of 5 years Data Management experience, specifically data review including patient profile experience, clinical data review, knowledge of medical terminology.
Company: Johnson & Johnson
Vacancy Type: Full Time
Job Location: Spring House, PA, US
Application Deadline: N/A