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Clinical Data Manager Intern
The Clinical Data Manager (CDM) intern is the Data Manager who, within the therapeutic area, is performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). Tapping into technical and clinical experience, the CDM closely collaborates with the SRP, SRS, Data Management functions and the rest of the study team members when implementing the data management related activities for protocols, with focus on more complex indication and therapy related elements of the study. As such, the CDM reviews all necessary data flows, the Data Management Plans and performs continuous (complex) data review activities on the studies in the assigned program.
De functie / The role
Impact of Decision‐Making: This position may make recommendations and influences decisions for specific trials or assignments.
Accountability/Decision‐Making: This position analyzes and provides input into decisions with direction from manager or Data Management Leader.
Supervision Received: This position receives ongoing direction to achieve objectives. Work is reviewed on a regular basis with the Data Management Leader.
Supervision Given: There are no direct reports for this position.
CDM works with more senior CDMs, GDM, SRP/SRS and other internal partners to establish, align and confirm Clinical data management expectations to the business for assigned trial(s).
CDM is involved in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
CDM supports (complex) scientific study data review, manages CDM and SRS/SRP related queries in eDC system and holds discussions with SRS/SRP. Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible. CDM leads and/or attends meetings as appropriate.
CDM will be exposed to data collection tools and data flows from study start up.
Contributes to the creation of the study Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. CDM reviews clinical data management documents for appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Works with GDM and DML to facilitate compliance with regulatory guidelines and the documentation matrix.
Works with DML to facilitate real‐time inspection readiness of all assigned deliverables for the trial. Participates in regulatory agency inspections and J&J internal audits as necessary.
Works with DML to plan and track applicable CDM deliverables.
Supports the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are met.
Identifies and communicates lessons learned with support from DML and frequently asked questions at trial level.
May participate in process, system, and tool improvement initiatives within DM.
Collaborates with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are met.
Het profiel / Your profile
Master/Bachelor degree in Business, Communications, or Management.
Tenslotte ..... / Finally ....
Janssen Biologics (7266)